CytoSorbents Corp. (NSDQ:CTSO) shares jumped 9% to $5.35 apiece today after the company reported that it landed a permanent reimbursement procedure code for its CytoSorb therapy in Germany.

The Monmouth Junction, N.J.-based company developed its blood purification therapy to treat inflammation in critically-ill patients and for use during cardiac surgery. CytoSorb is an extracorporeal cytokine filter, made up of biocompatible, porous polymer beads that use pore capture and surface adsorption to remove toxic substances from the blood and other bodily fluids.

Get the full story at our sister site, Medical Design & Outsourcing.

The post CytoSorbents gains on German reimbursement win appeared first on MassDevice.

Medtronic (NYSE:MDT) said today it partnered with Fitbit to integrate CGM data alongside physical activity data in Medtronic’s iPro2 myLog mobile application.

The partnership will allow type 2 diabetes patients to more effectively manage their diabetes by being able to monitor how exercise affects their glucose levels, Fridley, Minn.-based Medtronic said.

“We believe the integration of wearable technology with professional diagnostic tools can provide a more accurate and actionable view of a patient’s physical activity. By partnering with Medtronic, we are able to bring the power of Fitbit’s automatic activity tracking together with continuous glucose monitoring, allowing patients and providers to have a more informed conversation,” Fitbit digital health VP Adam Pellegrini said in prepared remarks.

The collaboration will also eliminate the need to manually record physical activity for many patients, Medtronic said, and will allow physical activity data to be easily shareable with the patients managing healthcare team.

“We believe monitoring glucose is a critical element in the management of diabetes and therefore, glucose should be included among other vital signs. As such, it has never been more important to increase the collaboration between healthcare and technology to simplify daily diabetes management for the 29 million patients living with type 2 diabetes in the United States. By creating a connection between physical activity and glucose levels, our iPro2 myLog mobile app solution provides new tools and insights, so that physicians can optimize therapy and patients can better understand how to manage their diabetes. By helping people with diabetes implement lasting lifestyle changes, this partnership underscores our commitment to transforming diabetes care, together, for greater freedom and better health,” Medtronic non-intensive diabetes therapies GM Laura Stoltenberg said in a press release.

In September, Medtronic announced the opening of a new headquarters for its non-intensive diabetes therapy business in Plymouth, Minn.

The newly opened facility will act as the global headquarters for the company’s NDT biz, as well as housing product development, research & development, marketing and operations, Medtronic said.

Earlier in September, the company said that data from a study of its closed-loop hybrid artificial pancreas, published in the Journal of the American Medical Assn., showed that the system is safe and effectively maintained blood glucose levels within range in Type I diabetes patients age 14 and older.

The post Medtronic, Fitbit ink CGM and physical activity data integration deal appeared first on MassDevice.

Abbott (NYSE:ABT) said today it filed a complaint with the Delaware Court of Chancery seeking to terminate its proposed $5.8 billion acquisition of Alere (NYSE:ALR), referencing a “substantial loss in Alere’s value.”

Illinois-based Abbott said that since signing its agreement to pick up Alere on January 30, the company has “suffered a series of damaging business developments.”

These include the permanent recall of a product platform, government elimination of billing privileges for an Alere division, multiple government and criminal subpoenas and a 5-month delay on its 10K filing, as well as admitting internal control failures which require a restatement of its 2013-2015 financials, Abbott said.

“Alere is no longer the company Abbott agreed to buy 10 months ago. These numerous negative developments are unprecedented and are not isolated incidents brought on by chance. We have attempted to secure details and information to assess these issues for months, and Alere has blocked every attempt. This damage to Alere’s business can only be the result of a systemic failure of internal controls, which combined with the lack of transparency, led us to filing this complaint,” Abbott external communications VP Scott Stoffel said in a press release.

Abbott said that under the terms of the merger agreement signed in January, the company may “terminate the transaction if adverse events materially change Alere’s long-term prospects.”

Shortly after Abbott announced the suit, Alere responded by saying that the filing is “entirely without merit.”

“As Abbott well knows, none of the issues it has raised provides it with any grounds to avoid closing the merger. Alere has fully complied with its contractual obligations under the merger agreement and is highly confident that the merger will be completed in accordance with the terms set forth in the merger agreement. Alere will take all actions necessary to protect its shareholders and to compel Abbott to complete the transaction in accordance with its terms,” Alere wrote in a press release.

Shares in Abbott have dipped just under 1%, trading at $38.10 as of 1:18 p.m. EST, while Alere’s shares have dropped nearly 9%, trading at $36.30 as of 1:18 p.m. EST.

The $5.8 billion deal, which was announced in February, ran into trouble right out of the gate. A March 11 subpoena from the U.S. Justice Dept. sought documents on Alere’s dealings with 3rd-party distributors and foreign healthcare officials and the company was late in filing its full-year results for 2015. Alere in April rejected a $50 million offer from Abbott to spike the merger; in July the DoJ initiated another probe into Alere’s billing practices for pain management payments from government insurance programs.

Alere sued Abbott the next month, looking to force its would-be acquirer to obtain all antitrust approvals required to complete the acquisition. In early September, Delaware Chancery Court Judge Sam Glasscock put the lawsuit on the fast track and urged the companies to try and talk things out; an attempt at mediation failed later that month.

Abbott filed its counter-suit last month, the same day that the Centers for Medicaid & Medicare Services revoked enrollment for Alere’s Arriva diabetes division after finding that it submitted claims for 211 deceased patients.

Abbott is hoping to close another deal, the $25 billion acquisition of St. Jude Medical (NYSE:STJ), by the end of this year. Anti-trust regulators in the European Union granted conditional approval to the merger in November. Alere alleges in its lawsuit against Abbott that its would-be acquirer got cold feet after inking the St. Jude deal in April.

The post Abbott files to terminate $6B Alere acquisition appeared first on MassDevice.

Mylan (NSDQ:MYL) shares dropped 5% this morning after it said in regulatory filing that it expects to cut less than 10% of its global workforce as a result of its restructuring efforts.

The Canonsburg, Penn.-based company has about 35,000 employees, according to Reuters, and wrote in the SEC filing that it will implement restructuring programs in specific locations in an effort to take cost-cutting measures following a number of acquisitions that it made in the past year. Mylan said it will disclose more details, including how much the efforts will cost, as the company finalizes its plans.

Get the full story at our sister site, Drug Delivery Business News.

The post Mylan to cut 10% of workforce in restructuring efforts appeared first on MassDevice.

Varian Medical (NYSE:VAR) said today that it will receive $200 million from its imaging components spin-off Varex Imaging in January as part of an updated separation deal.

The spin off will be a new, stand-alone public company separated through a tax-free distribution to Varian stockholders, the company said. Varex Imaging will borrow approximately $200 million to fund the transfer, Palo Alto, Calif.-based Varian Medical said.

“The imaging components business has gained momentum since last May when we announced the planned separation and we now believe that Varex can support this modest change in its planned capital structure. The cash transfer from Varex Imaging provides Varian with the means to reduce debt and conduct further share repurchases. It also positions us to execute our long term strategy, including supporting future strategic acquisitions,” CEO Dow Wilson said in prepared remarks.

Varian 1st announced its plans to spin-off the business in May this year. In July, Varian announced the Varex Imaging name for the spin-off.

Varian said the name was chosen to reflect “the 65-plus years of technology leadership and strong industry brand recognition of Varian and the excellence in X-ray imaging technology,” according to a press release.

The spun-off company will manufacture X-ray tubes, flat panel detectors, connectors and accessories for imaging, as well as supplying workstations and software for computer-aided diagnostics and image processing. Varex imaging will pursue its own growth strategies independent from Varian, through offering of components, software and services for expanded imaging applications and markets, according to the company.

The post Varian to receive $200m from Varex Imaging spin-off appeared first on MassDevice.

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD October 2016


TOTAL 510(k)s THIS PERIOD 235 
TOTAL WITH SUMMARIES      223 
TOTAL WITH STATEMENTS      12


DEVICE: EasyMap MAP Catheter
MedFact Engineering GmbH          510(k) NO: K151139(Traditional)
ATTN: Joerg  Reinhardt            PHONE NO : 49 7621 579820 
Hammerstr.3                       SE DECISION MADE: 18-OCT-16
Loerrach, Baden-Wurttemberg  DE D-510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow
SCHUTZ DENTAL GMBH                510(k) NO: K151399(Traditional)
ATTN: ANTJE  MAURER               PHONE NO : 49 0 60038140 
DIESELSTRASSE 5-6                 SE DECISION MADE: 24-OCT-16
ROSBACH  DE DE 61191              510(k) STATEMENT
                                                    

DEVICE: KJ Mini Implant System
KJ MEDITECH CO., LTD.             510(k) NO: K151970(Traditional)
ATTN: GOONG-SAN  NAM              PHONE NO : 82 62 9725476 
959-21 DAECHON-DONG, BUK-GU       SE DECISION MADE: 21-OCT-16
GWANG-JU  KR 959-21               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Painmaster MCT Patch
NEWMARK, INC.                     510(k) NO: K151995(Traditional)
ATTN: Francis  Powell             PHONE NO : 
131 Quarry Road                   SE DECISION MADE: 05-OCT-16
Cheshire CT  06410                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Pressure Transducer
ZHEJIANG HAISHENG MEDICAL DEVICE C510(k) NO: K152472(Traditional)
ATTN: Junbin  Hu                  PHONE NO : 86 575 88158510 
305#TANGGONG ROAD, PAOJIANG INDUSTSE DECISION MADE: 31-OCT-16
SHAOXING  CN 312071               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xonrid Gel
Helsinn Healthcare SA             510(k) NO: K152533(Traditional)
ATTN: Valentina  Tombolini Bossi  PHONE NO : 41 919 852121 
Via Pain Scairolo 9               SE DECISION MADE: 28-OCT-16
Lugano  CH 6912                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FilmArray Respiratory Panel EZ (RP EZ)
BIOFIRE DIAGNOSTICS, LLC          510(k) NO: K152579(Dual Track)
ATTN: KRISTEN J. KANACK           PHONE NO : 801 7366354 330
390 WAKARA WAY                    SE DECISION MADE: 03-OCT-16
SALT LAKE CITY UT  84108          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dynarex Xeroform Petrolatum Dressing
DYNAREX CORPORATION               510(k) NO: K152970(Traditional)
ATTN: JAMES   HURLMAN             PHONE NO : 845 3658200 
10 GLENSHAW STREET                SE DECISION MADE: 03-OCT-16
ORANGEBURG NY  10962              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: aoni Natural Rubber Latex Condom
Guangzhou Daming United Rubber Pro510(k) NO: K153016(Abbreviated)
ATTN: Yongbing  Xie               PHONE NO : 86 202268 08888687 
NO. 1 Daming Street, Port IndustriSE DECISION MADE: 20-OCT-16
Guangzhou  CN 510802              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Caremed patient cable and leadwires
SHENZHEN CAREMED MEDICAL TECHNOLOG510(k) NO: K153188(Traditional)
ATTN: XINLIN  XIAO                PHONE NO : 86 755 2714369 
ZONE B, 3/F, 11 BUILDING, HEBEI INSE DECISION MADE: 24-OCT-16
SHENZHEN  CN 518021               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ETIII SA Fixture System (O3.2mm)
HIOSSEN INC.                      510(k) NO: K153332(Traditional)
ATTN: PATRICK   LIM               PHONE NO : 888 6780001 
85 BEN FAIRLESS DR.               SE DECISION MADE: 27-OCT-16
FAIRLESS HILLS PA  19030          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IH Implant System
Sewon Medix Inc.                  510(k) NO: K153521(Traditional)
ATTN: Bum-keun  Park              PHONE NO : 82 51 3031713 
#29, Sa-sang-ro, 375beon-gil, Sa-sSE DECISION MADE: 14-OCT-16
Busan  KR 46946                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RS80A Diagnostic Ultrasound System
SAMSUNG MEDISON CO., LTD.         510(k) NO: K153539(Traditional)
ATTN: Kyeong-Mi  Park             PHONE NO : 82 2 21941373 
42, TEHERAN-RO 108-GIL,  GANGNAM-GSE DECISION MADE: 03-OCT-16
SEOUL  KR                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FTRD System Set
OVESCO ENDOSCOPY AG               510(k) NO: K153550(Traditional)
ATTN: MARC O. SCHURR              PHONE NO : 49 7071 98979121 
DORFACKERSTRASSE 26               SE DECISION MADE: 12-OCT-16
TUEBINGEN  DE 72074               510(k) STATEMENT
                                                    

DEVICE: FREND Testosterone Test System
NanoEnTek USA Inc.                510(k) NO: K153577(Traditional)
ATTN: Jimmy  Chen                 PHONE NO : 925 2250108 
5627 Stoneridge Drive Suite 304   SE DECISION MADE: 14-OCT-16
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sunmed Haemostatic Valves
SUNNY MEDICAL DEVICE (SHENZHEN) CO510(k) NO: K153685(Traditional)
ATTN: James  Qi  Zhang            PHONE NO : 949 2168838 
56 LEHIGH AISLE                   SE DECISION MADE: 13-OCT-16
IRVINE CA  92612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Volumetric Infusion Controller
DEKA RESEARCH & DEVELOPMENT       510(k) NO: K153760(Traditional)
ATTN: Julie   Perkins             PHONE NO : 603 6695139 
340 COMMERCIAL ST.                SE DECISION MADE: 03-OCT-16
MANCHESTER NH  03101              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: R:GEN Laser System
Lutronic Corporation              510(k) NO: K153769(Traditional)
ATTN: Jhung Won Vojir             PHONE NO : 82 31 9083440 
219, Sowon-ro, Deogyang-gu        SE DECISION MADE: 05-OCT-16
Goyang-si  KR 410-220             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NOSOGARD FILTERS
Evoqua Water Technologies, LLC    510(k) NO: K153784(Traditional)
ATTN: Robert  Dudek               PHONE NO : 978 6147359 
10 Technology Drive               SE DECISION MADE: 21-OCT-16
Lowell MA  01851                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DMi Dental Implant System
DMi Innovative Medical Technology 510(k) NO: K160060(Traditional)
ATTN: Yaniv Haim Buchacho         PHONE NO : 972 3 6225879 
84 Sokolov St,                    SE DECISION MADE: 03-OCT-16
Holon  IL 58330                   510(k) STATEMENT
                                                    

DEVICE: AUTION ELEVEN Semi-Automated Urinalysis System
ARKRAY, Inc.                      510(k) NO: K160062(Traditional)
ATTN: Tom  Speikers (U.S. Agent)  PHONE NO : 81 75 6628979 
Yousuien-Nai, 59 Gansuin-Cho      SE DECISION MADE: 07-OCT-16
Kamigyo-Ku  JP 602-0008           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rampart D Lumbar Interbody Fusion Device
Spineology Inc.                   510(k) NO: K160074(Traditional)
ATTN: Karen  Roche                PHONE NO : 651 2568500 
7800 Third Street North, Suite 600SE DECISION MADE: 18-OCT-16
Saint Paul MN  55128              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XCage™ Interbody Fusion System
Ouroboros Medical, Inc.           510(k) NO: K160076(Traditional)
ATTN: John  To                    PHONE NO : 510 9333456 
47757 Fremont Blvd                SE DECISION MADE: 13-OCT-16
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TENS Electrodes
CATHAY MANAFACTURING CORP.        510(k) NO: K160081(Traditional)
ATTN: Ren  Ren                    PHONE NO : 86 21 57878328 
No. 328, Xishe Road, Maogang Town,SE DECISION MADE: 19-OCT-16
Shanghai  CN 201607               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prestige Ameritech Pediatric/Child’s Face mask
Prestige Ameritech                510(k) NO: K160100(Traditional)
ATTN: RODNEY  GREGORY             PHONE NO : 817 4272700 
7201 Iron Horse Blvd.             SE DECISION MADE: 07-OCT-16
North Richland Hills TX  76180    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spetzler Malis Dual Illuminating Bipolar Forceps
SYNERGETICS                       510(k) NO: K160103(Traditional)
ATTN: DAN  REGAN                  PHONE NO : 636 7945013 
3845 CORPORATE CENTRE DRIVE       SE DECISION MADE: 12-OCT-16
O' FALLON MO  63368               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpiroScout
GANSHORN MEDIZIN ELECTRONIC GMBH  510(k) NO: K160116(Traditional)
ATTN: Stefan  Ponto               PHONE NO : 49 977 1622240 
INDUSTRIESTR 6-8                  SE DECISION MADE: 07-OCT-16
Niederlauer  DE 97618             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CorPath GRX System
Corindus, Inc.                    510(k) NO: K160121(Traditional)
ATTN: Michael  Douglas            PHONE NO : 508 6533335 
309 Waverley Oaks Road, Suite 105 SE DECISION MADE: 27-OCT-16
Waltham MA  02454                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: miraDry System
Miramar Labs, Inc.                510(k) NO: K160141(Traditional)
ATTN: Kathy  O'Shaughnessy        PHONE NO : 408 9408700 
2790 Walsh Avenue                 SE DECISION MADE: 31-OCT-16
Santa Clara CA  95051             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearVision ExamVue Flat Panel Detector
JPI HEALTHCARE, INC               510(k) NO: K160143(Traditional)
ATTN: JANG WON LEE                PHONE NO : 82 31 4913435 100
WOOLIM E-BIZ CENTER #608, 170-5   SE DECISION MADE: 28-OCT-16
KURO 3-DONG, KURO-GU  KR 152-769  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: I.B.S. 2.0 Osteosynthesis screw
In2Bones SAS                      510(k) NO: K160174(Traditional)
ATTN: Morgane  Grenier            PHONE NO : 33 472 292626 
28 chemin du Petit Bois           SE DECISION MADE: 06-OCT-16
ECULLY  FR 69130                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COLORADO THERAPEUTICS XENOGRAFT IMPLANT
Colorado Therapeutics LLC         510(k) NO: K160181(Traditional)
ATTN: WILLIAM  JACKSON            PHONE NO : 303 4699459 
2150 WEST 6TH AVENUE SUITE L      SE DECISION MADE: 20-OCT-16
BROOMFIELD CO  80020              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EnSite Velocity Surface Electrode Kit
ST. JUDE MEDICAL                  510(k) NO: K160186(Traditional)
ATTN: YUMI  WACKERFUSS            PHONE NO : 651 7562675 
ONE ST. JUDE MEDICAL DRIVE        SE DECISION MADE: 07-OCT-16
ST.PAUL MN  55117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0
ST. JUDE MEDICAL                  510(k) NO: K160187(Traditional)
ATTN: MELISSA  FRANK              PHONE NO : 651 7562954 
ONE ST. JUDE MEDICAL              SE DECISION MADE: 21-OCT-16
ST. PAUL MN  55117                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advocate Insulin Pen Needles
Diabetic Supply of Suncoast, Inc. 510(k) NO: K160199(Traditional)
ATTN: Victoria  Thuss             PHONE NO : 787 2706300 
Bo.Espinosa Carr.2km.26.2         SE DECISION MADE: 19-OCT-16
Dorado PR  00646-9532             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADAMANT ZIRCONIA DISC
Adamant Co., Ltd.                 510(k) NO: K160203(Traditional)
ATTN: Deborah Lavoie Grayeski     PHONE NO : 81 3 39191171 
1-16-7 Shinden, Adachi Ku         SE DECISION MADE: 19-OCT-16
Tokyo  JP 123-8595                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uVue HSG/SHG Catheter
COOK INCORPORATED                 510(k) NO: K160217(Traditional)
ATTN: Kara  Kanorr                PHONE NO : 812 3392235 104072
750 DANIELS WAY                   SE DECISION MADE: 06-OCT-16
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Visco (olifilcon A) soft contact lens
Visco Vision Inc                  510(k) NO: K160245(Traditional)
ATTN: Evan  Huang                 PHONE NO : 886 3 3596868 
No. 1, Xingye St., Guishan Dist., SE DECISION MADE: 24-OCT-16
Taoyuan  TW 33341                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SimulCare II(TM)
XANACARE TECHNOLOGIES, LLC        510(k) NO: K160246(Traditional)
ATTN: THOMAS C SIIROLA            PHONE NO : 720 5549262 
9185 EAST KENYON AVENUE # 270     SE DECISION MADE: 06-OCT-16
DENVER CO  80237-1857             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tempo Temporary Pacing Lead
BIO TRACE MEDICAL, INC.           510(k) NO: K160260(Traditional)
ATTN: Laura  N.  Dietch           PHONE NO : 650 7794742 
831 BRANSTEN RD, SUITE L          SE DECISION MADE: 25-OCT-16
SAN CARLOS CA  94070              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fingertip Pulse Oximeter MD300CG11/MD300CG51
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K160268(Traditional)
ATTN: LEI  CHEN                   PHONE NO : 86 108 8798300 6020
NO.9 SHUANGYUAN ROAD BADACHU HI-TESE DECISION MADE: 14-OCT-16
BEIJING  CN 100041                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANYVIEW-500R Fluoroscopic Mobile X-Ray System
ECOTRON CO.,LTD                   510(k) NO: K160279(Traditional)
ATTN: Sang  Bong  Lee             PHONE NO : 82 2 20253760 
RM 504, HANSHIN IT TOWER II, 47, DSE DECISION MADE: 14-OCT-16
SEOUL  KR 153-712                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles
PAJUNK GMBH MEDIZINTECHNOLOGIE    510(k) NO: K160294(Traditional)
ATTN: CHRISTIAN G.H. QUASS        PHONE NO : 49 077 049291586 
KARL-HALL STR. 1                  SE DECISION MADE: 21-OCT-16
GEISINGEN  DE 78187               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPROTTE NRFit, Quincke NRFit
PAJUNK GmbH Medizintechnologie    510(k) NO: K160295(Traditional)
ATTN: Christian G. H. Quass       PHONE NO : 49 0770 49291586 
Karl-Hall-Str. 1                  SE DECISION MADE: 27-OCT-16
Geisingen  DE 78187               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPROTTE SPECIAL NRFit
PAJUNK GMBH MEDIZINTECHNOLOGIE    510(k) NO: K160296(Traditional)
ATTN: CHRISTIAN G.H. QUASS        PHONE NO : 49 077 049291586 
KARL-HALL STR. 1                  SE DECISION MADE: 27-OCT-16
GEISINGEN  DE 78187               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tuohy NRFit
PAJUNK GmbH Medizintechnologie    510(k) NO: K160297(Traditional)
ATTN: Christian G.H. Quass        PHONE NO : 49 077 049291586 
Karl-Hall-Str. 1                  SE DECISION MADE: 28-OCT-16
Geisingen  DE 78187               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FRAXIS DUO 
ILOODA CO., LTD                   510(k) NO: K160312(Traditional)
ATTN: YUN JUNG HA                 PHONE NO : 82 263 662124 
120, JANGAN-RO 458 BEON-GIL JANGANSE DECISION MADE: 28-OCT-16
SUWON-SI  KR 100-85816200         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xenco Medical Cervical Interbody System
XENCO MEDICAL, LLC                510(k) NO: K160313(Traditional)
ATTN: GUSTAVO  PRADO              PHONE NO : 858 2021505 
9930 MESA RIM ROAD                SE DECISION MADE: 21-OCT-16
SAN DIEGO CA  92121               510(k) STATEMENT
                                                    

DEVICE: SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles
M.D.L. S.r.l.                     510(k) NO: K160316(Traditional)
ATTN: Marcello  Dell'Oca          PHONE NO : 39 0342 68213 
Via Tavani 1/a                    SE DECISION MADE: 27-OCT-16
Delebio (So)  IT 23014            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALADDIN HW3.0
VISIA IMAGING S.R.L               510(k) NO: K160327(Traditional)
ATTN: Silvia  Fantechi            PHONE NO : 39 055 9121635 
VIA MARTIRI DELLA LIBERTA 95/E    SE DECISION MADE: 05-OCT-16
San Giovanni Valdarno  IT 52027   510(k) STATEMENT
                                                    

DEVICE: MAGEC® Spinal Bracing and Distraction System
NuVasive Specialized Orthopedics, 510(k) NO: K160352(Traditional)
ATTN: LANCE  JUSTICE              PHONE NO : 949 5446540 
101 ENTERPRISE SUITE 100          SE DECISION MADE: 21-OCT-16
ALISO VIEJO CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OPTIMUS CMF SYSTEM
OSTEONIC Co., Ltd.                510(k) NO: K160363(Special)
ATTN: Jisun  Lee                  PHONE NO : 82 2 69028411 
1206ho, 38, Digital-ro 29-gil, GurSE DECISION MADE: 20-OCT-16
Seoul  KR                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NovaPACS
NOVARAD CORPORATION               510(k) NO: K160371(Traditional)
ATTN: DOUG  MERRILL               PHONE NO : 801 6421001 
752 EAST 1180 SOUTH #200          SE DECISION MADE: 14-OCT-16
AMERICAN FORK UT  84003           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyto Stethoscope
Tyto Care Ltd.                    510(k) NO: K160401(Traditional)
ATTN: Yoni  Iger                  PHONE NO : 972 54 9599215 
Haomanut 12                       SE DECISION MADE: 19-OCT-16
Netanya  IL 4205445               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers
NEURAL ANALYTICS, INC.            510(k) NO: K160442(Traditional)
ATTN: JAY  YONEMOTO               PHONE NO : 310 8191676 
2127 SAWTELLE BLVD                SE DECISION MADE: 21-OCT-16
LOS ANGELES CA  90025             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pleurx Pleural Catheter System
CAREFUSION                        510(k) NO: K160450(Traditional)
ATTN: JOY  GREIDANUS              PHONE NO : 847 3628103 
75 NORTH FAIRWAY DRIVE            SE DECISION MADE: 31-OCT-16
VERNON HILLS IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cutera enlighten III Laser System
Cutera, Inc.                      510(k) NO: K160488(Traditional)
ATTN: Bradley  Renton             PHONE NO : 415 6575568 
3240 Bayshore Blvd.               SE DECISION MADE: 28-OCT-16
Brisbane CA  94005                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITROS® Automation Solutions
Ortho-Clinical Diagnostics, Inc.  510(k) NO: K160495(Traditional)
ATTN: Darlene J Phillips          PHONE NO : 585 4534253 
100 Indigo Creek Drive MC00881    SE DECISION MADE: 18-OCT-16
Rochester NY  14626               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Link Abutment for CEREC
Osstem Implant Co., Ltd           510(k) NO: K160519(Traditional)
ATTN: Hee  Kwon                   PHONE NO : 82 51 8502575 
66-16, Bansong-ro 513beon-gil, HaeSE DECISION MADE: 28-OCT-16
Busan  KR 612-070                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control
SYSMEX AMERICA, INC.              510(k) NO: K160541(Traditional)
ATTN: Michelle   Parker           PHONE NO : 224 5439639 
577 Aptakisic Road                SE DECISION MADE: 21-OCT-16
Lincolnshire IL  60069            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NOBLUS™ Ultrasound Diagnostic System
HITACHI MEDICAL CORPORATION       510(k) NO: K160559(Traditional)
ATTN: ANGELA VAN ARSDALE          PHONE NO : 203 2695088 
10 FAIRFIELD BLVD.                SE DECISION MADE: 18-OCT-16
WALLINGFORD CT  06492-7502        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
HARTALEGA SND. BHD.               510(k) NO: K160562(Traditional)
ATTN: KUAN KAM HON                PHONE NO : 60 36277 1733 
C-G-1, JALAN DATARAN SD1 DATARAN SSE DECISION MADE: 13-OCT-16
BANDAR SRI DAMANSARA  MY 52200    510(k) STATEMENT
                                                    

DEVICE: REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
VOLCANO CORPORATION               510(k) NO: K160583(Traditional)
ATTN: BRIAN  PARK                 PHONE NO : 858 7204176 
3721 VALLEY CENTRE DRIVE SUITE 500SE DECISION MADE: 26-OCT-16
SAN DIEGO CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENROUTE 0.014" Guidewire
LAKE REGION MEDICAL               510(k) NO: K160643(Traditional)
ATTN: MICHAEL  DUNNING            PHONE NO : 35 391 385037 
PARKMORE  W BUSINESS PARK         SE DECISION MADE: 18-OCT-16
GALWAY  IE G07001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dentiq3D
3D INDUSTRIAL IMAGING CO.,LTD.    510(k) NO: K160666(Traditional)
ATTN: Jin  Sa Kim                 PHONE NO : 82 70 87669192 
413 Institute Of Computer TechnoloSE DECISION MADE: 05-OCT-16
Gwanak-gu  KR                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReNew V Handpiece Laparoscopic Instruments
MICROLINE SURGICAL, INC.          510(k) NO: K160706(Traditional)
ATTN: ANU  GAUR                   PHONE NO : 978 8671726 
50 DUNHAM ROAD, SUITE 1500        SE DECISION MADE: 19-OCT-16
BEVERLY MA  01915                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LumFix Spinal Fixation Sytem
CG BIO CO., LTD.                  510(k) NO: K160731(Traditional)
ATTN: YUNA  JEONG                 PHONE NO : 82 317 320840 
244, GALMACHI-RO, JUNGWON-GU      SE DECISION MADE: 04-OCT-16
SEONGNAM-SI  KR 13211             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BracePaste Adhesive
American Orthodontics             510(k) NO: K160782(Traditional)
ATTN: Trang  Adams                PHONE NO : 920 4575051 
3524 Washington Avenue            SE DECISION MADE: 14-OCT-16
Sheboygan WI  53081               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rockwell Medical CitraPure Acid Concetrate
ROCKWELL MEDICAL                  510(k) NO: K160847(Traditional)
ATTN: ROBERT  CHIOINI             PHONE NO : 248 9609009 
30142 WIXOM ROAD                  SE DECISION MADE: 20-OCT-16
WIXOM MI  48393                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cryotop Vitrification Kit and Cryotop Thawing Kit
KITAZATO BIOPHARMA CO., LTD.      510(k) NO: K160864(Traditional)
ATTN: FUTOSHI  INOUE              PHONE NO : 81 545 662202 
81 NAKIJIMA                       SE DECISION MADE: 07-OCT-16
FUJI  JP 416-0907                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PaX-i3D Green Premium (Model: PCT-90LH)
VATECH CO., LTD                   510(k) NO: K160882(Traditional)
ATTN: Daniel   Kim                PHONE NO : 82 313 799492 
13, SAMSUNG 1-RO 2-GIL            SE DECISION MADE: 28-OCT-16
HWASEONG-SI  KR 18449             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HemosIL D-Dimer HS
INSTRUMENTATION LABORATORY CO.    510(k) NO: K160885(Special)
ATTN: CAROL  MARBLE               PHONE NO : 781 8614467 
180 HARTWELL ROAD                 SE DECISION MADE: 27-OCT-16
BEDFORD MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ATTO Mobility Scooter
Moving Life Ltd                   510(k) NO: K160909(Traditional)
ATTN: Nino A. Ransenberg          PHONE NO : 972 54 5745678 
HaOfe 2                           SE DECISION MADE: 04-OCT-16
Kadima  IL 6092000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterilization Tray
STERIS CORPORATION                510(k) NO: K160912(Traditional)
ATTN: ANTHONY  PIOTRKOWSKI        PHONE NO : 440 3927437 
5960 HEISLEY ROAD                 SE DECISION MADE: 07-OCT-16
MENTOR OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gammex Cut-Resistant Glove Liner
ANSELL HEALTHCARE PRODUCTS LLC    510(k) NO: K160974(Traditional)
ATTN: ROBERT  MAHLER              PHONE NO : 732 3455400 
111 WOOD AVENUE SOUTH SUITE 210   SE DECISION MADE: 28-OCT-16
ISELIN NJ  08830                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pantera Pro
BIOTRONIK, INC                    510(k) NO: K160985(Traditional)
ATTN: Jon  Brumbaugh              PHONE NO : 888 3450374 
6024  JEAN ROAD                   SE DECISION MADE: 07-OCT-16
LAKE OSWEGO OR  97035             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HPM-6000
BTL INDUSTRIES, INC.              510(k) NO: K160992(Traditional)
ATTN: JAN  ZARSKY                 PHONE NO : 866 2851656 
47 LORING DRIVE                   SE DECISION MADE: 21-OCT-16
FRAMINGHAM MA  01702              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HICP200 Patient/Monitor Interconnect Cable
InnerSpace Neuro Solutions, Inc.  510(k) NO: K161010(Traditional)
ATTN: Gary G. Frugard             PHONE NO : 877 4862473 108
1622 Edinger Ave Suite C          SE DECISION MADE: 20-OCT-16
Tustin CA  92780                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Z-Clamp ISP System
Zavation, LLC                     510(k) NO: K161016(Traditional)
ATTN: James M Philips             PHONE NO : 601 9191119 
220 Lakeland Parkway              SE DECISION MADE: 19-OCT-16
Flowood MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PK Morcellator
GYRUS ACMI, INC.                  510(k) NO: K161038(Traditional)
ATTN: GRAHAM A.L. BAILLIE         PHONE NO : 508 8042738 
136 TURNPIKE RD                   SE DECISION MADE: 07-OCT-16
SOUTHBOROUGH MA  02649            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack
Kuraray Noritake Dental, Inc.     510(k) NO: K161042(Traditional)
ATTN: Michio  Takigawa            PHONE NO : 81 3 67011706 
Ote Center Bldg. 7F, 1-1-3, OtemacSE DECISION MADE: 25-OCT-16
Chiyoda ku  JP 100-0004           510(k) STATEMENT
                                                    

DEVICE: ACTABOND Topical Skin Adhesive
BERGEN MEDICAL PRODUCTS, INC.     510(k) NO: K161050(Traditional)
ATTN: Tom    Stephens             PHONE NO : 855 8553682 703
16 WING DRIVE                     SE DECISION MADE: 04-OCT-16
Cedar Knolls NJ  07927            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator
Surgitools Pty Ltd.               510(k) NO: K161065(Traditional)
ATTN: Jai  Singh                  PHONE NO : 61 08 93093222 
231 Timberlane Dr.                SE DECISION MADE: 27-OCT-16
Woodvale  AU 6026                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Klassic HD Hip System
Total Joint Othopedics, Inc.      510(k) NO: K161073(Traditional)
ATTN: Chris  Weaber               PHONE NO : 801 4866070 
1567 E. Stratford Avenue          SE DECISION MADE: 19-OCT-16
Salt Lake City UT  84106          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arrow Epidural Catheter Kit
TELEFLEX MEDICAL, INC.            510(k) NO: K161075(Traditional)
ATTN: ANGELA  BOUSE               PHONE NO : 919 4334904 
3015 CARRINGTON MILL BLVD         SE DECISION MADE: 04-OCT-16
MORRISVILLE NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iSR'obot MRI-US Fusion
BIOBOT SURGICAL PTE LTD           510(k) NO: K161109(Traditional)
ATTN: Lai Chee LIEW               PHONE NO : 65 635 11868 
2 WOODLANDS SPECTRUM 1,  #03-10, WSE DECISION MADE: 06-OCT-16
Singapore  SG 738068              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearPetra Suction-Evacuation Sheath
WELL LEAD MEDICAL CO., LTD.       510(k) NO: K161110(Traditional)
ATTN: Han  Guang  Yuan            PHONE NO : 86 20 84758878 
C-4#Jinhu Industrial Estate, HualoSE DECISION MADE: 12-OCT-16
Guangzhou  CN 511434              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navien Intracranial Support Catheter
MICRO THERAPEUTICS, INC. D/B/A EV3510(k) NO: K161152(Traditional)
ATTN: Ingrid   Takeuchi           PHONE NO : 949 2979774 
9775 TOLEDO WAY                   SE DECISION MADE: 12-OCT-16
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iNSitu Total Hip System
Theken Companies, LLC             510(k) NO: K161184(Traditional)
ATTN: Dale  Davison               PHONE NO : 330 7337600 
1800 Triplett Blvd.               SE DECISION MADE: 14-OCT-16
Akron OH  44306                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PLEX Elite 9000 SS-OCT
CARL ZEISS MEDITEC, INC.          510(k) NO: K161194(Traditional)
ATTN: CHRISTINE  DUNBAR           PHONE NO : 925 5605139 
5160 HACIENDA DRIVE               SE DECISION MADE: 26-OCT-16
DUBLIN CA  94568                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: e-fix E35/E36
Alber GmbH                        510(k) NO: K161241(Traditional)
ATTN: MICHAEL  VENT               PHONE NO : 49 7432 20060 
Vor dem Weissen Stein 21          SE DECISION MADE: 05-OCT-16
Albstadt  DE 72461                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W
MEDICO ELECTRODES INTERNATIONAL LT510(k) NO: K161282(Traditional)
ATTN: AMIT   SETH                 PHONE NO : 91 120 3042984 
PLOT 142A/AA, 12, 27, 28 & 29, NOISE DECISION MADE: 30-OCT-16
NOIDA  IN 201305                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MiniBox +
PULMONE ADVANCED MEDICAL DEVICES, 510(k) NO: K161295(Traditional)
ATTN: Avi   Lazar                 PHONE NO : 972 77 5100938 
14 HACHAROSHET ST                 SE DECISION MADE: 21-OCT-16
Ra’ananna  IL 4365707             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pour Acrylic
Dentsply Sirona                   510(k) NO: K161330(Traditional)
ATTN: Helen  Lewis                PHONE NO : 717 4871332 
221 West Philadelphia Street SuiteSE DECISION MADE: 06-OCT-16
York PA  17404                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NanoBone SBX Putty
ARTOSS GMBH                       510(k) NO: K161351(Traditional)
ATTN: Walter  Gerike              PHONE NO : 49 381 54345701 
FRIEDRICH-BARNEWITZ-STR. 3        SE DECISION MADE: 26-OCT-16
ROSTOCK  DE 18119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HawkOne Directional Atherectomy System
Medtronic Vascular, Inc.          510(k) NO: K161361(Traditional)
ATTN: Rupali  Gupta               PHONE NO : 763 3987000 
(formerly d.b.a ev3 Inc., CovidienSE DECISION MADE: 14-OCT-16
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Orbiter ST Steerable Diagnostic EP Catheter
Innovative Health, LLC.           510(k) NO: K161393(Traditional)
ATTN: Rafal  Chudzik              PHONE NO : 480 5256006 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 26-OCT-16
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VT·One, VT·One 60days
CARILEX MEDICAL, INC.             510(k) NO: K161410(Traditional)
ATTN: Henry   Kao                 PHONE NO : 886 3 3287882 
No. 77, Keji 1st Rd., Guishan DistSE DECISION MADE: 13-OCT-16
Taoyuan City  TW 333              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
WRP ASIA PACIFIC SDN. BHD.        510(k) NO: K161422(Traditional)
ATTN: SARALA DEVI JAYARAMAN       PHONE NO : 6 03 87061486 
LOT 1, JALAN 3, KAW PERUSAHAAN BANSE DECISION MADE: 20-OCT-16
 SEPANG   MY 43900                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeoSpan Compression Staple Impant w/instruments
IN2BONESUSA, LLC                  510(k) NO: K161426(Traditional)
ATTN: JOE  CLIFT                  PHONE NO : 901 2607931 
6060 POPLAR AVE, SUITE 380        SE DECISION MADE: 24-OCT-16
MEMPHIS TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HydroSet XT
ORTHOVITA, INC.                   510(k) NO: K161447(Traditional)
ATTN: TINA  MORNAK                PHONE NO : 610 6401775 
45 GREAT VALLEY PARKWAY           SE DECISION MADE: 06-OCT-16
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Footmotion Plating System
NEWCLIP TECHNICS                  510(k) NO: K161448(Traditional)
ATTN: Gaelle  Lussori             PHONE NO : 33 228 213712 
PA de la Lande Saint Martin-45 rueSE DECISION MADE: 31-OCT-16
HAUTE-GOULAINE  FR 44 115         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HammerTech Fixation System
Fusion Orthopedics, LLC           510(k) NO: K161449(Traditional)
ATTN: Adam  Cundiff               PHONE NO : 800 4036876 
4135 S. Power Rd., Suite 110      SE DECISION MADE: 11-OCT-16
Mesa AZ  85212                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care
Indiba USA Inc.                   510(k) NO: K161458(Traditional)
ATTN: Carles  Janer               PHONE NO : 650 8139700 
1717 Embarcadero Road             SE DECISION MADE: 03-OCT-16
Palo Alto CA  94303               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MR Syringe Dual Pack for Solaris Injectors
Coeur, Inc.                       510(k) NO: K161471(Traditional)
ATTN: Priscilla  Clinner          PHONE NO : 615 5477923 
100 Physicians Way                SE DECISION MADE: 06-OCT-16
Lebanon TN  37090                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)
MEDLINE, INDUSTRIES, INC.         510(k) NO: K161473(Traditional)
ATTN: Jennifer  Mason             PHONE NO : 847 6433652 
ONE MEDLINE PLACE                 SE DECISION MADE: 19-OCT-16
MUNDELEIN IL  60060               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: R2 Dermal Cooling System
R2 Dermatology                    510(k) NO: K161480(Traditional)
ATTN: Kristine  Tatsutani         PHONE NO : 925 3784400 
Bishop Ranch 3 2633 Camino Ramon  SE DECISION MADE: 05-OCT-16
San Ramon CA  94583               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ambient HipVac 50 Wand with Integrated Finger Switches
ARTHROCARE CORPORATION            510(k) NO: K161481(Traditional)
ATTN: Ashley  M.  Johnston        PHONE NO : 512 3585762 
7000 WEST WILLIAM CANNON DRIVE    SE DECISION MADE: 21-OCT-16
AUSTIN TX  78735                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unger Quad Injector
STRADIS HEALTHCARE                510(k) NO: K161483(Traditional)
ATTN: Joseph   Trznadel           PHONE NO : 847 5967716 
805 MARATHON PKWY SUITE 100       SE DECISION MADE: 31-OCT-16
LAWRENCEVILLE GA  30046           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Turbo-Flo PICC Sets
COOK INCORPORATED                 510(k) NO: K161496(Traditional)
ATTN: Steven   Lawrie             PHONE NO : 812 3353575 104518
750 DANIELS WAY                   SE DECISION MADE: 07-OCT-16
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental Implants and Abutments
Ditron Precision Ltd              510(k) NO: K161497(Traditional)
ATTN: Moshe  Orlev                PHONE NO : 972 86 711841 
Haofe 2 St., P.O Box 5010         SE DECISION MADE: 28-OCT-16
Netanya  IL 78150                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ELEOS Limb Salvage System
Onkos Surgical, Inc.              510(k) NO: K161520(Traditional)
ATTN: Jan  Triani                 PHONE NO : 973 2645400 
77 East Halsey Road               SE DECISION MADE: 28-OCT-16
Parsippany NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OTC TENS Device, Model PTS-IV
COUNTER SCIENTIFIC DEVELOPMENT (GZ510(k) NO: K161537(Traditional)
ATTN: WENDY  POON                 PHONE NO : 86 203 8289980 
2ND &3RD FLOOR, BLD.6 DAPIAN INDUSSE DECISION MADE: 13-OCT-16
GUANGZHOU  CN 510665              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advanced Breast Template System
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K161540(Traditional)
ATTN: Peter  J.  Coronado         PHONE NO : 650 6469200 
911 HANSEN WAY                    SE DECISION MADE: 20-OCT-16
PALO ALTO CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: R2P SlenGuide
ASHITAKA FACTORY OF TERUMO CORPORA510(k) NO: K161546(Traditional)
ATTN: PHEBE  VARGHESE             PHONE NO : 732 4124166 
150 MAIMAIGI-CHO                  SE DECISION MADE: 14-OCT-16
FUJINOMIYA SHIZUOKA  JP 418-0015  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KARL STORZ NAV1 Electromagnetic Navigation System
KARL STORZ Endoscopy America, Inc.510(k) NO: K161555(Traditional)
ATTN: Leigh  Spotten              PHONE NO : 424 2188738 
2151 E. Grand Ave                 SE DECISION MADE: 21-OCT-16
El Segundo CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fingertip Pulse Oximeter MD300CN310
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K161560(Traditional)
ATTN: LEI  CHEN                   PHONE NO : 86 108 8798300 6020
NO.9 SHUANGYUAN ROAD, BADACHU HI-TSE DECISION MADE: 05-OCT-16
Beijing  CN 100041                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws
Howmedica Osteonics Corp. aka Stry510(k) NO: K161569(Traditional)
ATTN: Valerie  Giambanco          PHONE NO : 201 8316275 
325 Corporate Drive               SE DECISION MADE: 14-OCT-16
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Esophagus Bougie Set
Varian Medical Systems, Inc.      510(k) NO: K161576(Traditional)
ATTN: Peter J. Coronado           PHONE NO : 650 4246320 
911 Hansen Way                    SE DECISION MADE: 02-OCT-16
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Premier Sealant
PREMIER DENTAL COMPANY PRODUCTS   510(k) NO: K161580(Traditional)
ATTN: VINCENT  D'ALESSANDRO       PHONE NO : 610 2396000 
1710 ROMANO DRIVE                 SE DECISION MADE: 18-OCT-16
PLYMOUTH MEETING PA  19462        510(k) STATEMENT
                                                    

DEVICE: ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16
ASAHI INTECC CO.,LTD.             510(k) NO: K161584(Traditional)
ATTN: Yoshihiko   Fukui           PHONE NO : 81 52 7681211 
1703 WAKITA-CHO, MORIYAMA-KU      SE DECISION MADE: 06-OCT-16
NAGOYA  JP 463-0024               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OSSTEM Implant System
OSSTEM IMPLANT CO., LTD.          510(k) NO: K161604(Traditional)
ATTN: Hee  Kwon                   PHONE NO : 82 51 8502575 
66-16, BANSONG-RO 513BEON-GIL, HAESE DECISION MADE: 17-OCT-16
Busan  KR 612-070                 510(k) STATEMENT
                                                    

DEVICE: Smart External Drain (SED) System
AQUEDUCT CRITICAL CARE, INC.      510(k) NO: K161605(Traditional)
ATTN: Thomas  Clement             PHONE NO : 425 9851571 
11822 NORTH CREEK PARKWAY NORTH  SSE DECISION MADE: 27-OCT-16
Bothell WA  98011                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAVUX™ Cervical Cage
PROVIDENCE MEDICAL TECHNOLOGY, INC510(k) NO: K161642(Traditional)
ATTN: Margaret  Wong              PHONE NO : 415 9239376 
1331 N. CALIFORNIA BLVD., SUITE 32SE DECISION MADE: 07-OCT-16
WALNUT CREEK CA  94596            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QuantumCam
DDD-DIAGNOSTIC A/S                510(k) NO: K161674(Abbreviated)
ATTN: Niels  Sorensen             PHONE NO : 45 45 768888 
DR. NEERGAARDS VEJ 5E             SE DECISION MADE: 20-OCT-16
HORSHOLM  DK 2970                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Q13 SPIROLYSER®
FIM MEDICAL                       510(k) NO: K161676(Traditional)
ATTN: LIZA  PERRAT                PHONE NO : 33 047 2348989 
51 RUE PRIMAT CS 60194            SE DECISION MADE: 20-OCT-16
Villeurbanne Cedex , Rhone  FR 696510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann Sterile Healing Solution
Institut Straumann AG             510(k) NO: K161677(Traditional)
ATTN: Christopher  Klaczyk        PHONE NO : 41 61 9651260 
Peter Merian Weg 12               SE DECISION MADE: 07-OCT-16
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantum LB
Reliance Orthodontic Products Inc.510(k) NO: K161684(Traditional)
ATTN: Paula  Wendland             PHONE NO : 630 7734009 
1540 West Thorndale Ave           SE DECISION MADE: 06-OCT-16
Itasca IL  60143                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: D-10 Hemoglobin A1c Program
BIO-RAD LABORATORIES, INC.        510(k) NO: K161687(Traditional)
ATTN: JACKIE  BUCKLEY             PHONE NO : 510 7415309 
4000 ALFRED NOBEL DR.             SE DECISION MADE: 14-OCT-16
HERCULES CA  94547                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acclarent NavWire Sinus Navigation Guidewire
ACCLARENT, INC.                   510(k) NO: K161697(Traditional)
ATTN: ANNA  HWANG                 PHONE NO : 949 7898505 
33 TECHNOLOGY DRIVE               SE DECISION MADE: 24-OCT-16
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Relieva UltirraNav Sinus Balloon Catheter
ACCLARENT, INC.                   510(k) NO: K161698(Traditional)
ATTN: JAMES PATRICK GARVEY        PHONE NO : 949 7898505 
33 TECHNOLOGY DRIVE               SE DECISION MADE: 24-OCT-16
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CARTO ENT System
BIOSENSE WEBSTER                  510(k) NO: K161701(Traditional)
ATTN: MELISSA C. SCHULTZ          PHONE NO : 909 8398500 
3333 DIAMOND CANYON ROAD          SE DECISION MADE: 24-OCT-16
DIAMOND BAR CA  91765             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
IMMUNALYSIS CORPORATION           510(k) NO: K161714(Traditional)
ATTN: JOSEPH  GINETE              PHONE NO : 909 4820840 
829 TOWNE CENTER DRIVE            SE DECISION MADE: 14-OCT-16
POMONA CA  91767                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MaxBlend 2, MaxBlend Lite
Maxtec, LLC                       510(k) NO: K161718(Traditional)
ATTN: Bruce  Brierley             PHONE NO : 385 5498070 
2305 South 1070 West              SE DECISION MADE: 27-OCT-16
Salt Lake City UT  84119          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Standard Clamp
STANDARD BARIATRICS               510(k) NO: K161720(Traditional)
ATTN: Alison  Sathe               PHONE NO : 513 3047971 
4362 GLENDALE MILFORD RD.         SE DECISION MADE: 24-OCT-16
CINCINNATI OH  45242              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail
MEDELA, INC                       510(k) NO: K161725(Traditional)
ATTN: ROBERT  SOKOLOWSKI          PHONE NO : 815 5782220 
1101 CORPORATE DRIVE              SE DECISION MADE: 28-OCT-16
MCHENRY IL  60050                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Eyenez Ophthalmic Camera
EYENEZ LLC                        510(k) NO: K161727(Traditional)
ATTN: DR.  KISLINGER              PHONE NO : 626 3350535 
2619 E.COLORADO BLVD              SE DECISION MADE: 04-OCT-16
PASADENA CA  91107                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CapsoCam Plus (SV-3) Capsule Endoscope System
CapsoVision, Inc                  510(k) NO: K161773(Traditional)
ATTN: Azimun  Jamal               PHONE NO : 408 6241488 
18805 Cox Ave., Suite 250         SE DECISION MADE: 21-OCT-16
Saratoga CA  95070                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearLumen II Thrombectomy System
Walk Vascular, LLC                510(k) NO: K161786(Traditional)
ATTN: David  Look                 PHONE NO : 949 7529642 
17171 Daimler Street              SE DECISION MADE: 18-OCT-16
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avance Tubing, Avance Y-Connector, Avance ViewPad
MOLNLYCKE HEALTH CARE, US LLC     510(k) NO: K161797(Traditional)
ATTN: MEGAN  BEVILL               PHONE NO : 470 3750049 
5550 PEACHTREE PARKWAY SUITE 500  SE DECISION MADE: 19-OCT-16
NORCROSS GA  30092                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band
Genesee BioMedical, Inc.          510(k) NO: K161815(Traditional)
ATTN: Woodrow G. Mathison         PHONE NO : 303 7773000 
700 W. Mississippi Ave Unit D-5   SE DECISION MADE: 12-OCT-16
Denver CO  80223-4509             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Torcon NB Advantage Catheters
Cook Incorporated                 510(k) NO: K161822(Special)
ATTN: Jennifer  Allman            PHONE NO : 812 3353575 104280
750 Daniels Way                   SE DECISION MADE: 27-OCT-16
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: kneeEOS
ONEFIT Medical                    510(k) NO: K161828(Traditional)
ATTN: Julien  Simon               PHONE NO : 33 381 252427 
18 Rue Alain Savary               SE DECISION MADE: 03-OCT-16
Besancon  FR 25000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zimmer M/L Taper Hip Prosthesis
ZIMMER, INC.                      510(k) NO: K161830(Special)
ATTN: RHONDA  MYER                PHONE NO : 574 3719659 
P.O. BOX 708                      SE DECISION MADE: 26-OCT-16
Warsaw IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Overwatch Spine System
Amendia, Inc.                     510(k) NO: K161842(Traditional)
ATTN: Bruce  Hooper               PHONE NO : 877 7553329 
1755 West Oak Parkway             SE DECISION MADE: 13-OCT-16
Marietta GA  30062                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Automatic Arm Bluetooth Blood Pressure Monitor
TRULY INSTRUMENT LIMITED          510(k) NO: K161846(Abbreviated)
ATTN: YANG  JIAN-HO               PHONE NO : 86 0660 3380070 
SITE 2, TRULY INDUSTRY AREA       SE DECISION MADE: 24-OCT-16
SHANWEI  CN 516600                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Glass Ionomer Cement (Luting)
SHANDONG HUGE DENTAL MATERIAL CORP510(k) NO: K161851(Traditional)
ATTN: STEVEN  SONG                PHONE NO : 086 633 2277285 
No. 68 Shanhai Road, Donggang DistSE DECISION MADE: 31-OCT-16
Rizhao City  CN 276800            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS
THE BINDING SITE GROUP LTD        510(k) NO: K161854(Traditional)
ATTN: ANDREA  THOMAS              PHONE NO : 44 012 14569500 
8 CALTHORPE ROAD                  SE DECISION MADE: 04-OCT-16
EDGBASTON  GB B15 1QT             510(k) STATEMENT
                                                    

DEVICE: PreXion3D Excelsior
PreXion Corporation               510(k) NO: K161881(Traditional)
ATTN: Shumpeita  Torii            PHONE NO : 81 3 52977551 
Funai Tokyo Technology Center BuilSE DECISION MADE: 03-OCT-16
Chiyoda-ku  JP 101-0041           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CUSA Clarity Ultrasonic Surgical Aspirator System
INTEGRA LIFESCIENCES CORPORATION  510(k) NO: K161882(Traditional)
ATTN: RESHAM  RAMSAY              PHONE NO : 609 9365529 
311 ENTERPRISE DRIVE              SE DECISION MADE: 14-OCT-16
PLAINSBORO NJ  08536              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Cellfina System
ULTHERA, INC.                     510(k) NO: K161885(Traditional)
ATTN: SUZON  LOMMEL               PHONE NO : 480 6454979 
1840 S Stapley Drive, Suite 200   SE DECISION MADE: 05-OCT-16
Mesa AZ  85204                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device
GUANGDONG TRANSTEK MEDICAL ELECTRO510(k) NO: K161886(Special)
ATTN: ADA  ZHANG                  PHONE NO : 086 760 85166358 
ZONE B, No.105, DONGLI ROAD, TORCHSE DECISION MADE: 14-OCT-16
ZHONGSHAN  CN 528437              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neuromonitoring Kit
SI-BONE, INC.                     510(k) NO: K161893(Traditional)
ATTN: ROXANNE  DUBOIS             PHONE NO : 408 2070700 2236
3055 OLIN AVE, SUITE 2200         SE DECISION MADE: 18-OCT-16
SAN JOSE CA  95128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings
KCI USA, INC. (KINETIC CONCEPTS, I510(k) NO: K161897(Traditional)
ATTN: MARGARET  MARSH             PHONE NO : 210 2556481 
6203 FARINON DRIVE                SE DECISION MADE: 04-OCT-16
SAN ANTONIO TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip
ASAHI INTECC CO., LTD.            510(k) NO: K161912(Special)
ATTN: Yasuyuki  Kawahara          PHONE NO : 81 52 7681211 
1703 Wakita-cho, Moriyama-ku      SE DECISION MADE: 14-OCT-16
Nagoya  JP 463-0024               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CO2 Laser Therapy Machine
Beijing ADSS Development Co., Ltd 510(k) NO: K161925(Traditional)
ATTN: Gao  Yurong                 PHONE NO : 86 10 83625120 
F6, Xiandao Bldg., Jinyuan Rd. 36 SE DECISION MADE: 05-OCT-16
Beijing  CN 102628                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Toricolors (hioxifilcon D) Soft Contact Lenses
POLYDEV LTD.                      510(k) NO: K161931(Traditional)
ATTN: JOHN  MULVIHILL             PHONE NO : 353 87 6873128 
TINURE RD                         SE DECISION MADE: 12-OCT-16
COLLON  IE                        510(k) STATEMENT
                                                    

DEVICE: CuattroDR
Cuattro, LLC                      510(k) NO: K161937(Traditional)
ATTN: Matthew  Taylor             PHONE NO : 970 752247 
3760 Rocky Mountain Avenue        SE DECISION MADE: 06-OCT-16
Loveland CO  80538                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulsaderm Acne Device
NUTRA LUXE MD, LLC                510(k) NO: K161941(Traditional)
ATTN: GLORIA  AVENDANO            PHONE NO : 239 2087549 
12801 COMMONWEALTH DR. UNIT 2-6   SE DECISION MADE: 19-OCT-16
FORT MYERS FL  33913              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: bk2300
BK MEDICAL APS                    510(k) NO: K161960(Traditional)
ATTN: MICHAEL J. DOYLE            PHONE NO : 978 3264410 
MILEPARKEN 34                     SE DECISION MADE: 17-OCT-16
HERLEV  DK 2730                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADVIA Centaur HAV IgM Assay
Siemens Healthcare Diagnostics, In510(k) NO: K161964(Traditional)
ATTN: Philip  Liu                 PHONE NO : 914 5242443 
511 Benedict Avenue               SE DECISION MADE: 13-OCT-16
Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: G-scan Brio, S-scan
Esaote S.p.A.                     510(k) NO: K161973(Traditional)
ATTN: Maria  Marzapane            PHONE NO : 011 39 0554229259 
Via Siffredi 58                   SE DECISION MADE: 25-OCT-16
Genova  IT 16153                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ziehm Solo FD
ZIEHM IMAGING GMBH                510(k) NO: K161976(Traditional)
ATTN: RICHARD L. WESTRICH         PHONE NO : 490 911 2172219 
DONAUSTRASSE 31                   SE DECISION MADE: 06-OCT-16
NUREMBERG  DE D-90451             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Olive Plus
AMA NETWORK INC                   510(k) NO: K161981(Traditional)
ATTN: YONG BAIK KIMM              PHONE NO : 909 2747700 
3600 WILSHIRE BLVD #1016          SE DECISION MADE: 14-OCT-16
LOS ANGELES CA  90010             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MedDream
SOFTNETA UAB                      510(k) NO: K162011(Traditional)
ATTN: LAURA  BARONIENE            PHONE NO : 370 68835432 
K.BARAUSKO STR. 59                SE DECISION MADE: 14-OCT-16
KAUNAS  LT 51423                  510(k) STATEMENT
                                                    

DEVICE: IntelliSpace Portal Platform
PHILIPS MEDICAL SYSTEMS NEDERLANDS510(k) NO: K162025(Third Party - Traditional)
ATTN: Ilana Ben Moshe             PHONE NO : 972 525 233496 
VEENPLUIS 4-6 Room 542A           SE DECISION MADE: 18-OCT-16
BEST  NL 5684 PC                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TRAcelet Compression Device
MEDTRONIC VASCULAR                510(k) NO: K162027(Traditional)
ATTN: COLLEEN  MULLINS            PHONE NO : 978 7393267 
37A CHERRY HILL DRIVE             SE DECISION MADE: 21-OCT-16
DANVERS MA  01923                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 16ch T/R Knee Coil
Quality Electrodynamics, LLC      510(k) NO: K162029(Traditional)
ATTN: Kathleen  Aras              PHONE NO : 440 4842964 
6655 Beta Drive, Suite 100        SE DECISION MADE: 18-OCT-16
Mayfield Village OH  44143        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medtronic Temporary External Pacemaker 53401
MEDTRONIC, INC.                   510(k) NO: K162054(Traditional)
ATTN: SYED SUMRAN MOHIUDDIN       PHONE NO : 763 5262380 
8200 CORAL SEA STREET NE          SE DECISION MADE: 18-OCT-16
MOUNDS VIEW MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ahmed Glaucoma Valve
NEW WORLD MEDICAL, INC.           510(k) NO: K162060(Traditional)
ATTN: SUHAIL  ABDULLAH            PHONE NO : 909 4664304 
10763 EDISON COURT                SE DECISION MADE: 24-OCT-16
RANCHO CUCAMONGA CA  91730        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M.U.S.T. Pedicle Screw System
MEDACTA INTERNATIONAL SA          510(k) NO: K162061(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
STRADA REGINA                     SE DECISION MADE: 21-OCT-16
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultrasound System SONIMAGE HS1
KONICA MINOLTA, INC.              510(k) NO: K162065(Traditional)
ATTN: Tsutomu  Fukui              PHONE NO : 81 42 5898429 
1 Sakura-machi                    SE DECISION MADE: 19-OCT-16
Hino-shi  JP 191-8511             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: chromID MRSA
bioMerieux, Inc.                  510(k) NO: K162076(Traditional)
ATTN: Karen  Russell              PHONE NO : 314 7318639 
595 Anglum Road                   SE DECISION MADE: 25-OCT-16
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
Tandem Diabetes Care, Inc.        510(k) NO: K162080(Traditional)
ATTN: Michael  Sarrasin           PHONE NO : 858 3666900 
11045 Roselle Street              SE DECISION MADE: 25-OCT-16
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NIRO-200NX DP
Hamamatsu Photonics K.K.          510(k) NO: K162117(Traditional)
ATTN: Susumu  Suzuki              PHONE NO : 81 53 4310124 
812 Joko-cho, Higashi-ku          SE DECISION MADE: 25-OCT-16
Hamamatsu City  JP 431-3196       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive CoRoent Small Ti-C System
NUVASIVE, INCORPORATED            510(k) NO: K162138(Traditional)
ATTN: MICHELLE  CHEUNG            PHONE NO : 858 9093360 
7475 LUSK BLVD.                   SE DECISION MADE: 26-OCT-16
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: vRad PACS with Mammography
Virtual Radiologic Corporation    510(k) NO: K162145(Abbreviated)
ATTN: Melinda  Sewell             PHONE NO : 952 5951100 
11995 Singletree Lane, Suite 500  SE DECISION MADE: 25-OCT-16
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BreathID Hp Lab System
Exalenz Bioscience Ltd.           510(k) NO: K162150(Traditional)
ATTN: Raffi  Werner               PHONE NO : 972 8 9737521 
4 Ha'Maayan Street                SE DECISION MADE: 31-OCT-16
Modiin  IL 7177872                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EdgeOne CO2 Laser
Jeisys Medical Inc.               510(k) NO: K162169(Traditional)
ATTN: Erica  Seo                  PHONE NO : 1 714 9225276 
307 Daeryung Techno Town 8th 81-11SE DECISION MADE: 27-OCT-16
Seoul Seoul Teugbyeolsi  KR 153-77510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sapphire NC Plus
OrbusNeich Medical, Inc           510(k) NO: K162209(Special)
ATTN: John D. Pazienza            PHONE NO : 954 7300711 
5363 NW 35th Avenue               SE DECISION MADE: 06-OCT-16
Fort Lauderdale FL  33309         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FortiBridge Anterior Cervical Plate System
NANOVIS SPINE LLC                 510(k) NO: K162250(Special)
ATTN: MATTHEW  HEDRICK            PHONE NO : 877 9076266 
5865 EAST STATE RD. 14            SE DECISION MADE: 26-OCT-16
COLUMBIA CITY IN  46725           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Klassic Femur, Porous, Klassic Tibial Baseplate, Porous
TOTAL JOINT ORTHOPEDICS, INC.     510(k) NO: K162256(Traditional)
ATTN: CHRIS  WEABER               PHONE NO : 801 4866070 
1567 E. STRATFORD AVENUE          SE DECISION MADE: 27-OCT-16
SALT LAKE CITY UT  84106          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Voluson E6, Voluson E8, Voluson E10
GE Healthcare                     510(k) NO: K162269(Special)
ATTN: Bryan  Behn                 PHONE NO : 414 7214214 
9900 Innovation Drive, Milwaukee CSE DECISION MADE: 03-OCT-16
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fluent inflation device
VASCULAR SOLUTIONS, INC.          510(k) NO: K162272(Special)
ATTN: BEKA  VITE                  PHONE NO : 763 6575732 
6464 SYCAMORE COURT NORTH         SE DECISION MADE: 20-OCT-16
MINNEAPOLIS MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solana Strep Complete Assay
Quidel Corporation                510(k) NO: K162274(Traditional)
ATTN: Ronald H Lollar             PHONE NO : 740 5893373 
2005 East State Street, Suite 100 SE DECISION MADE: 25-OCT-16
Athens OH  45701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeraQuest Herpes Type 1 Specific IgG
QUEST INTERNATIONAL, INC          510(k) NO: K162276(Traditional)
ATTN: DAVID J. KIEFER             PHONE NO : 305 5926991 
8127 NW 29TH STREET               SE DECISION MADE: 01-OCT-16
MIAMI FL  33122                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyLabSix CrystaLine
ESAOTE S.P.A.                     510(k) NO: K162290(Traditional)
ATTN: MASSIMO  POLIGNANO          PHONE NO : 39 010 65471 
VIA A. SIFFREDI 58                SE DECISION MADE: 14-OCT-16
GENOVA  IT 16153                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens
ST. SHINE OPTICAL CO., LTD.       510(k) NO: K162317(Traditional)
ATTN: ELLA  LEE                   PHONE NO : 886 2 26479356 
4,5F NO. 276-2, SEC. 1, TA TUNG RDSE DECISION MADE: 21-OCT-16
NEW TAIPEI CITY  TW 22146         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled
Avinger, Inc                      510(k) NO: K162326(Traditional)
ATTN: Patty  Hevey                PHONE NO : 650 2417004 
400 Chesapeake Drive              SE DECISION MADE: 18-OCT-16
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker OrthoMap Precision Knee system
Stryker Leibinger GmbH & Co. KG   510(k) NO: K162341(Traditional)
ATTN: N/A  N/A                    PHONE NO : 
Boetzinger Strasse 41             SE DECISION MADE: 12-OCT-16
Freiburg  DE D-79111              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Erisma® LP MIS
CLARIANCE SAS                     510(k) NO: K162367(Traditional)
ATTN: Pascal  ROKEGEM             PHONE NO : 33 3 21161215 
18, rue Robespierre               SE DECISION MADE: 27-OCT-16
BEAURAINS  FR 62217               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.via RT Image Suite
Siemens Medical Solutions USA, Inc510(k) NO: K162370(Traditional)
ATTN: Kimberly  Mangum            PHONE NO : 610 4486477 
40 Liberty Blvd., Mail Code 65-1A SE DECISION MADE: 25-OCT-16
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KATOR Suture Anchor
KATOR LLC                         510(k) NO: K162386(Special)
ATTN: Robert  Hoy                 PHONE NO : 614 4486358 
124 South 600 West Suite 100      SE DECISION MADE: 25-OCT-16
Logan UT  84321                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Express SD Biliary Monorail Premounted Stent System
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K162404(Traditional)
ATTN: Ka Zoua Xiong               PHONE NO : 763 4942970 
ONE SCIMED PLACE                  SE DECISION MADE: 12-OCT-16
Maple Grove MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FIREFLY® Pedicle Screw Navigation Guide
MIGHTY OAK MEDICAL INC.           510(k) NO: K162419(Traditional)
ATTN: Mark A. Wylie               PHONE NO : 720 3989703 
750 W. HAMPDEN AVENUE SUITE 120   SE DECISION MADE: 28-OCT-16
Englewood CO  80110               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Klassic Knee System
Total Joint Orthopedics, Inc.     510(k) NO: K162422(Special)
ATTN: Chris  Weaber               PHONE NO : 801 4866070 
1567 E. Stratford Avenue          SE DECISION MADE: 28-OCT-16
Salt Lake City UT  84106          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ulna Plating System
BIOMET INC                        510(k) NO: K162424(Traditional)
ATTN: Julie  Largent              PHONE NO : 305 2696391 
56 E BELL DR                      SE DECISION MADE: 12-OCT-16
WARSAW IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Codman EDS3 CSF External Drainage System
Codman & Shurtleff, Inc.          510(k) NO: K162437(Traditional)
ATTN: Christopher  Garete         PHONE NO : 508 9773869 
325 PARAMOUNT DR.                 SE DECISION MADE: 28-OCT-16
RAYNHAM MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PowerPICC Provena Catheters
C.R. BARD, INC.                   510(k) NO: K162443(Special)
ATTN: BRYAN  STONE                PHONE NO : 801 5225876 
605 NORTH 5600 WEST               SE DECISION MADE: 25-OCT-16
SALT LAKE CITY UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LiVac Retractor System
Livac Pty Ltd                     510(k) NO: K162445(Traditional)
ATTN: Anabela  Correia            PHONE NO : 61 41 2003606 
8 Melaleuca Court                 SE DECISION MADE: 20-OCT-16
Warrnambool  AU 3280              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps
Medos International SARL          510(k) NO: K162469(Traditional)
ATTN: Jennifer  Siu               PHONE NO : 508 8283288 
Chemin-Blanc 38                   SE DECISION MADE: 26-OCT-16
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Artemis
EIGEN                             510(k) NO: K162474(Traditional)
ATTN: William  Mandel             PHONE NO : 530 2741240 
13366 GRASS VALLEY AVE            SE DECISION MADE: 21-OCT-16
GRASS VALLEY CA  95945            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BSD3543 Digital Flat Panel X-ray Detector
BONTECH INC.                      510(k) NO: K162487(Special)
ATTN: KWANG S. CHOI               PHONE NO : 82 31 3035254 
YOUNGTONG-GU YOUNGTONG-DONG 980-3,SE DECISION MADE: 14-OCT-16
SUWON-SI  KR 443-702              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CD HORIZON® Spinal System
MEDTRONIC SOFAMOR DANEK USA, INC  510(k) NO: K162494(Special)
ATTN: Justin  O'Connor            PHONE NO : 901 3463133 
1800 PYRAMID PLACE                SE DECISION MADE: 04-OCT-16
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SKR 3000
KONICA MINOLTA, INC               510(k) NO: K162504(Traditional)
ATTN: TSUTOMU  FUKUO              PHONE NO : 81 42 5898429 
1 SAKURA-MACHI                    SE DECISION MADE: 03-OCT-16
HINO-SHI  JP 191-8511             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arterys Software v2.0
ARTERYS INC.                      510(k) NO: K162513(Third Party - Traditional)
ATTN: GOLNAZ  MOEINI              PHONE NO : 408 5043187 
51 FEDERAL ST. SUITE 305          SE DECISION MADE: 28-OCT-16
SAN FRANCISCO CA  94107           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Multichem A1c
Technopath Manufacturing          510(k) NO: K162514(Abbreviated)
ATTN: Bernd  Hass                 PHONE NO : 00353 61 525700 
Fort Henry Business Park          SE DECISION MADE: 26-OCT-16
Ballina  IE                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 1012WCC, 1012WGC
RAYENCE CO., LTD.                 510(k) NO: K162518(Special)
ATTN: KEVIN  KIM                  PHONE NO : 82 31 80156459 
14, SAMSUNG 1-RO, 1-GIL           SE DECISION MADE: 06-OCT-16
HWASEONG-SI  KR 445-170           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 1717WCC / 1717WGC
RAYENCE CO., LTD                  510(k) NO: K162519(Special)
ATTN: KEVIN  KIM                  PHONE NO : 82 31 80156459 
14, SAMSUNG 1-RO, 1-GIL           SE DECISION MADE: 06-OCT-16
HWASEONG-SI  KR 445-170           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Viveve System
Viveve Inc.                       510(k) NO: K162547(Special)
ATTN: Jim  Talbot                 PHONE NO : 408 4703206 
150 Commercial Street             SE DECISION MADE: 06-OCT-16
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumify Ultrasound System
Philips Healthcare                510(k) NO: K162549(Third Party - Traditional)
ATTN: Chuck  Morreale             PHONE NO : 425 4877371 
22100 Bothell Everett Highway     SE DECISION MADE: 03-OCT-16
Bothell WA  98021-8411            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Medtronic Model 5392 External Pulse Generator (EPG)
Medtronic, Inc.                   510(k) NO: K162550(Special)
ATTN: Brenna  Loufek              PHONE NO : 763 5262365 
8200 Coral Sea Street NE          SE DECISION MADE: 12-OCT-16
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gentrix Surgical Matrix
Acell, Inc.                       510(k) NO: K162554(Special)
ATTN: Salman  Elmi                PHONE NO : 410 9538500 
6640 Eli Whitney Drive            SE DECISION MADE: 21-OCT-16
Columbia MD  21046                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bioflux Software
Biotricity Inc.                   510(k) NO: K162571(Third Party - Traditional)
ATTN: Tom  Elias                  PHONE NO : 416 2144215 
75 International Blvd, Suite 300  SE DECISION MADE: 13-OCT-16
Toronto  CA M9W 6L9               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VascuCel
Admedus Regen Pty Ltd             510(k) NO: K162579(Special)
ATTN: Mary E. Donlin              PHONE NO : 610 8 92660100 
26 Harris Road                    SE DECISION MADE: 14-OCT-16
Malaga  AU 6090                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VersaOne Bladeless Trocar
COVIDIEN                          510(k) NO: K162584(Special)
ATTN: TRANG  HUYNH                PHONE NO : 203 4927473 
60 MIDDLETOWN AVE                 SE DECISION MADE: 18-OCT-16
NORTH HAVEN CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HDL-Cholesterol Gen.4
Roche Diagnostics Operations (RDO)510(k) NO: K162593(Traditional)
ATTN: Barbara  McWhorter          PHONE NO : 317 5212336 
9115 Hague Road                   SE DECISION MADE: 19-OCT-16
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AIR OPTIX COLORS
Alcon Laboratories, Inc.          510(k) NO: K162596(Special)
ATTN: Sherri  Lakota              PHONE NO : 817 6155472 
6201 South Freeway                SE DECISION MADE: 13-OCT-16
Fort Worth TX  76134-2099         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
Alcon Laboratories, Inc.          510(k) NO: K162597(Special)
ATTN: Sherri  Lakota              PHONE NO : 817 6155472 
6201 South Freeway                SE DECISION MADE: 19-OCT-16
Fort Worth TX  76134-2099         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IcePearl 2.1 CX L, IceForce 2.1 CX L
GALIL MEDICAL LTD.                510(k) NO: K162599(Special)
ATTN: LYNNE  DAVIES               PHONE NO : 621 2875098 
TAVOR 1 BUILDING, INDUSTRIAL PARK,SE DECISION MADE: 11-OCT-16
SHAAR YOKNEAM  IL 2069203         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NovoPen Echo
Novo Nordisk Inc.                 510(k) NO: K162602(Special)
ATTN: Elizabeth  D'Amato          PHONE NO : 609 9197789 
P.O. Box 846                      SE DECISION MADE: 18-OCT-16
Plainsboro NJ  08536              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infinix, INFX-8000V, V6.35
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K162614(Special)
ATTN: PAUL  BIGGINS               PHONE NO : 714 6697808 
1385 SHIMOISHIGAMI                SE DECISION MADE: 17-OCT-16
OTAWARA-SHI  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fujifilm Endoscope Models EC-600HL and EC-600LS
FUJIFILM Medical Systems U.S.A., I510(k) NO: K162622(Special)
ATTN: Shraddha  More              PHONE NO : 937 6862627 
10 High Point Drive               SE DECISION MADE: 18-OCT-16
Wayne NJ  07470                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IQM Integral Quality Monitor (also "IQM")
IRT SYSTEMS                       510(k) NO: K162629(Third Party - Traditional)
ATTN: Juergen  Oellig             PHONE NO : 49 261 915450 
SCHLOSSTRASSE 1                   SE DECISION MADE: 20-OCT-16
Koblenz  DE 56068                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Distal Radius Plating System
Miami Device Solutions, LLC       510(k) NO: K162635(Special)
ATTN: Michelle  Montesino         PHONE NO : 786 4221400 
7620 NW 25th Street, Unit 3       SE DECISION MADE: 21-OCT-16
Miami FL  33122                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Green Smart (Model: PHT-35LHS)
VATECH CO., LTD                   510(k) NO: K162660(Special)
ATTN: Daniel  Kim                 PHONE NO : 82 31 3799585 
13, SAMSUNG 1-RO 2-GIL            SE DECISION MADE: 20-OCT-16
HWASEONG-SI  KR 445-170           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pyrenees Cervical Plate System
K2M, Inc.                         510(k) NO: K162664(Special)
ATTN: NANCY  GIEZEN               PHONE NO : 703 7773155 
600 HOPE PKWY SE                  SE DECISION MADE: 07-OCT-16
LEESBURG VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Paragon 2
MERIDIAN MEDICAL SYSTEMS, LLC     510(k) NO: K162687(Traditional)
ATTN: Larry  Cornell              PHONE NO : 216 5331124 
325 HARRIS DRIVE                  SE DECISION MADE: 21-OCT-16
AURORA OH  442027539              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: truFreeze System
CSA MEDICAL, INC.                 510(k) NO: K162695(Special)
ATTN: SHERRIE  COVAL-GOLDSMITH    PHONE NO : 781 5384720 
91 HARTWELL AVENUE                SE DECISION MADE: 25-OCT-16
LEXINGTON MA  02421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene
SeaSpine Orthopedics Corporation  510(k) NO: K162715(Special)
ATTN: Gina  Flores                PHONE NO : 760 2165136 
5770 Armada Drive                 SE DECISION MADE: 28-OCT-16
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT
Siemens Medical Solutions USA, Inc510(k) NO: K162736(Traditional)
ATTN: ALAINE  MEDIO               PHONE NO : 865 2182703 
810 INNOVATION DRIVE              SE DECISION MADE: 25-OCT-16
KNOXVILLE TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AxoGuard Nerve Connector
COOK BIOTECH INCORPORATED         510(k) NO: K162741(Special)
ATTN: PERRY W. GUINN              PHONE NO : 765 4973355 
1425 INNOVATION PLACE             SE DECISION MADE: 31-OCT-16
WEST LAFAYETTE IN  47906          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Libra Pedicle Screw System
Spinal Balance, Inc.              510(k) NO: K162750(Special)
ATTN: Anand  Agarwal              PHONE NO : 419 5305940 
1510 North Westwood Avenue        SE DECISION MADE: 27-OCT-16
Toledo OH  43606                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuroBlate System
Monteris Medical, Inc.            510(k) NO: K162762(Special)
ATTN: David H. Mueller            PHONE NO : 763 2534710 
14755 27th Avenue North; Suite C  SE DECISION MADE: 26-OCT-16
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Squirt Fluid Delivery System
Merit Medical Systems, Inc.       510(k) NO: K162777(Special)
ATTN: Angela  Brady               PHONE NO : 801 3164818 
1600 W Merit Parkway              SE DECISION MADE: 31-OCT-16
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA

The post FDA releases October 2016 510(k) clearances appeared first on MassDevice.

One Drop said today that it won 510(k) clearance from the FDA and CE Mark clearance for its One Drop | Chrome blood glucose monitoring system. The system is a part of One Drop | Premium, which the company touts as the 1st-ever monthly subscription service for affordable diabetes care.

The subscription service includes unlimited blood glucose testing supplies and 24/7 in-app support from diabetes experts, according to the company. One Drop claimed that diabetes costs $825 billion per year in direct costs, healthcare services, loss of productivity, and disability, while its service costs $39.95 or less each month without insurance.

The One Drop | Premium service also includes a cloud-bates diabetes management app for iOS and Android, which allows subscribers and their healthcare providers to monitor real-time and historical blood glucose data.

“One Drop is designed by people with diabetes for people with diabetes, and One Drop | Chrome is a perfect embodiment of our vision,”  CEO & founder, Jeff Dachis said in prepared remarks. “We’re transforming the diabetes management experience by designing empowering, beautiful products people love to use, while also delivering outstanding evidence-based results.”

The company also touted a preliminary analysis of recent data collected from its users over the course of 4 consecutive weeks. The data showed that users consistently tracked their food and blood glucose levels, increased their average number of in-range blood glucose readings by 40%, and reduced their average percentage of high blood glucose readings from 18.5% to 3.7%.

“It’s crucial that any diabetes solution drives evidence-based results,” said Dachis. “With One Drop | Premium, we are delivering a well-designed, evidence-based diabetes solution that offers accessible, affordable, scalable, comprehensive care to anyone, anywhere in the world. In doing so, we empower everyone with diabetes to make better choices, lead fuller lives, and achieve meaningful improvements in their health outcomes.”

The post One Drop wins FDA nod, CE Mark for mobile blood glucose monitor appeared first on MassDevice.

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

Get this in your inbox everyday by subscribing to our newsletters.

5. Baxter releases infusion pump programming software

Baxter launched its Sigma Spectrum Safety Management System this week at the American Society of Health-System Pharmacists meeting. The infusion pump system consists of an analytics software and a suite of remote professional services for cyber-security monitoring.

The Deerfield, Ill.-based company said its Sigma Spectrum system was developed to minimize infusion pump programming risks, with features like direct integration with electronic medical record systems and automatically connecting infusion pumps to installed drug libraries. The safety management system includes an infusion analytics application, which creates infusion data analyses and graphical reporting to help identify pump programming errors. Read more

4. Abyrx raises $10m, inks soft-tissue adhesive deal with Bezwada Biomedical

Abyrx said today it raised $10 million in a new equity financing round and expanded its exclusive, global license agreement with Bezwada Biomedical to include the development and production of Bezwada’s soft-tissue adhesive tech.

Funds in the $10 million round came from Canaan Partners, MedEdge, BB Biotech Ventures and members of the company’s executive team, with funds slated to support Abyrx’s bone putty products and to accelerate pipeline developments. Read more

3. FDA adds high-risk indication to Abiomed’s Impella CP heart pump

Abiomed said today that it won an expanded indication from the FDA for its Impella CP heart pump for high-risk patients.

The Impella CP device, which won pre-market approval earlier this year for up to 4 hours of treating patients for cardiogenic shock after acute myocardial infarction or cardiac surgery, can now be used to for up to 6 hours during high-risk percutaneous coronary interventions, Danvers, Mass.-based Abiomed said. Read more

2. J&J joins $7m OrthoSpace funding round

OrthoSpace said it has closed a $7 million round of equity financing, being joined by newly vested medtech giant Johnson & Johnson.

OrthoSpace produces the InSpace orthopedic biodegradable balloon system designed for minimally invasive rotator cuff repair procedures. Read more

1. Chinese anti-trust regulators ding Medtronic for $17m

Chinese anti-trust regulators dinged MDT for more than $17 million for price fixing with its cardiovascular and diabetes devices.

The ¥118.5 million fine levied by China’s National Development & Reform Commission on Medtronic (Shanghai) Management Co. stemmed from an investigation into the company’s dealings with local distributors. Medtronic sought to monopolize those markets by fixing prices and setting lower limits on resale prices to hospitals. Read more

The post MassDevice.com +5 | The top 5 medtech stories for December 7, 2016 appeared first on MassDevice.

Baxter (NYSE:BAX) is laying off 12 employees from its Bloomington, Ind. facilities, according to a report from The Herald Times.

The dismissals mark the 2nd round for the company at its Bloomington facilities, following the layoff of 36 employees in 2015.

“For the past several months, the leadership team at our Bloomington facility has been strategically managing attrition and related backfill of positions, as well as reducing the use of temporary workers, in order to minimize the impact of any necessary reductions in our workforce” Baxter global communications director wrote, according to The Herald Times.

The laid-off employees spanned several different departments and functions, according to the report. The Bloomington facilities, which were acquired by Baxter in 2001, employ a total of 650 people.

Last month, Baxter’s board of directors approved a $1.5 billion increase in its share repurchase plan as it announced its quarterly cash dividend of 13¢.

The share repurchase plan, which was approved in 2012, now has $1.9 billion to repurchase shares. Baxter said it will engage in repurchasing “at times and amounts determined by the company based on its evaluation of market conditions and other factors.”

The post Baxter lays off 12 at Bloomington facilities appeared first on MassDevice.

The U.S. Senate voted 94-5 today to pass the 21st Century Cures Act, sending the measure to President Barack Obama, who is likely to sign it into law soon.

The U.S. House voted to pass the healthcare measure by a vote of 392-26 last week. Supporters of the bill say it will spur medical innovation by speeding up the regulatory process for device-makers and pharmaceutical companies, while expanding access to mental health treatment and battle the ongoing opioid epidemic. But critics, like Sen. Elizabeth Warren (D-Mass.) and Sen. Bernie Sanders (D-Vermont), have said the bill gives hand-outs to the pharmaceutical industries and cuts public health programs.

The $6.3 billion measure, which has been 2 years in the making, was sponsored by Rep. Fred Upton (R-Michigan) and authorizes $4.8 billion for the National Institutes of Health and $500 million to the FDA. The bill includes provisions which allow clinical trials for devices and drugs to be designed with fewer patients and simpler goals.

“The 21st Century Cures Act is a true victory for every patient and our health care system,” Sen. Pat Roberts (R-Kansas) said in a statement.

The bill included $1.8 billion in funding for Vice President Joseph Biden’s Cancer Moonshot initiative to improve cancer research by encouraging collaboration and reducing the bureaucracy.

“AdvaMed commends the Senate for passing this important piece of legislation. The 21^st Century Cures Act is a win for patients and for medical innovation. When fully implemented, this legislation will help accelerate the discovery, development and delivery of medical advancements to ensure more timely access to new treatments and cures for patients in need,” Scott Whitaker, president & CEO of the Advanced Medical Technology Association, said in a statement. “AdvaMed has been a strong proponent of the 21^st Century Cures Initiative from its earliest stages. We are pleased that this legislation – which will have such a positive impact for patients and the American innovation ecosystem – has passed one more hurdle to becoming a reality. We urge the president to sign this bipartisan bill into law as expeditiously as possible so patients can begin benefiting from its many reforms.”

The post U.S. Senate passes 21st Century Cures Act appeared first on MassDevice.

Aerie Pharmaceuticals (NSDQ:AERI) said today that it completed enrollment for its 2nd phase III registration trial, Mercury 2, evaluating its Roclatan once-daily eye drops for intraocular pressure resulting from glaucoma or ocular hypertension.

The company’s Roclatan solution is a fixed dose combination of its drug Rhopressa (netarsudil ophthalmic solution) and latanoprost, a widely prescribed prostaglandin analogue. More than 690 patients are enrolled in the 3-arm study, comparing the Roclatan solution to each of its individual components.

Get the full story at our sister site, Drug Delivery Business News.

The post Aerie completes enrollment of phase III trial for intraocular pressure eye drops appeared first on MassDevice.

Researchers from the Caboolture Hospital in Queensland, Australia found that medical skin glue can be used to hold hospital intravenous lines in place, significantly reducing the risk of infection, pain, blockage or overall failure. The team’s work was published in the Annals of Emergency Medicine.

The Emergency Medicine Foundation of Australia, along with Queensland Health, funded the research and patient trials, which EMF said ran for several months at Caboolture Hospital. The work is undergoing a cost-benefit analysis by health economists at Griffith University. The lead researcher, Dr. Simon Bugden, said that within the 1st 48 hours, IV lines have a failure rate of 29-40% in Australia and can be as high as 90% internationally.

Get the full story at our sister site, Drug Delivery Business News.

The post Study finds medical skin glue can reduce IV drip failure appeared first on MassDevice.

Terumo Corp. (TYO:4543) said today it reached an agreement with Abbott (NYSE:ABT) and St. Jude Medical (NYSE:STJ) to acquire vascular products from both companies in connection to their $25 billion merger.

The deal will include St. Jude’s Angio-Seal and FemoSeal vascular closure product lines and Abbott’s Vado steerable sheath. Together, the total annual sales of the businesses are approximately $268 million, Terumo said.

“The acquisition, which brings us leading vascular closure devices, will enable Terumo to provide customers with a comprehensive product offering in minimally invasive entry site management and lesion access. We expect that the acquisition will enhance our presence in the United States, which is the largest market for medical devices,” prez & CEO Yutaro Shintaku said in a press release.

Japan-based Terumo said the acquisition will allow it to “maximize the value of the acquired businesses and contribute to supporting safe and efficient interventional procedures.”

The company originally announced the deal to pick up the assets from the merging company in October. Abbott said it expects to “mitigate” any impact on its adjusted earnings per share from the asset sale to Terumo.

The post Terumo moves forward on $1B deal to pick up St. Jude, Abbott vascular assets appeared first on MassDevice.

Sanovas recently announced the launch of SinuGeniX, a wholly-owned subsidiary focused on treating chronic sinusitis with the company’s RegENT sinus treatment system.

The newly-launched subsidiary won’t just supply a single tool for treating chronic sinusitis, which affects over 28 million Americans, but a suite of technologies, Sanovas CEO and system co-inventer Larry Gerrans told MassDevice.com in an interview.

“I wanted to create the tool belt, not just the tool. We’ve created a number of very complimentary tools that will improve physicians access and imaging along with the treatment procedure and measurement. It runs with the theme which I’ve always had, which is that you have to AIM – access, image and measure. Then you have the ability to perform diagnostics and treatment,” Gerrans said.

The company looks to deliver a suite of technologies to handle the procedure, Gerrans said. Included in the RegENT system are a deflectable needle for improved anesthetization, advanced procedural visualization through a smart, semi-compliant balloon catheter designed for maintaining healthy anatomy, and navigation with an articulated guide-sheath.

“Peer reviewed data suggests that more than 20% of the 13 million U.S. patients that are treated with medication for chronic sinusitis fail to respond.  So, there are about 2.6 million patients looking to surgery as an ultimate solution. However, current treatments in sinus surgery aren’t precise and come with complications,” chief medical officer & co-inventor of RegENT Dr. Chris Baker said in a press release.

Gerrans said he helped create the system after noticing a number of new balloon sinuplasty technologies come to market, and questioning their impact on the bony sinus ostia in the nose. Side effects of existing balloon sinuplasty procedures include bleeding, loss of olfactory sensation, aesthetic conditions and empty nose syndrome, according to Gerrans.

“What we know about current balloon sinuplasty technologies is that they essentially widen the sinus, and they fracture the sinus ostia. That can lead to bleeding, scarring, recurrent stenosis and revision procedures, and we’re seeing that in the data now,” Gerrans said. “I invented a novel system of measurement called OsteoSense. Essentially what that does is it creates a smart balloon catheter that can measure the relative levels of deformation of the sinus ostia so that you can sequentially and rhythmically inflate and deflate the balloon within the sinus to open it, relieve congestion, remodel the sinus cavity and mitigate sinus ostia fracture, while preserving the patient’s anatomy.”

For an office-based procedure to proceed well, Gerrans said, appropriate anesthetization was especially important. And often, in current balloon sinuplasty procedures, anesthetization isn’t perfect, and can leave patients incredibly uncomfortable.

“Patients start to get anxiety, they feel like they can’t breathe, their eyes tear up and its uncomfortable. A lot of patients don’t tolerate office-based sinusitis procedures very well. If you can imagine, you’re sitting right in front of the brain, below the eyes, you have all that sensory perception going on, you’re smelling it, you’re feeling it, you can almost see it, it can be maddening,” Gerrans said.

The company’s system looks to improve upon visualization in balloon sinuplasty procedures as well, Gerrans said. Traditionally, balloon sinuplasty procedures operate on transcutaneous illumination, which involves light projected through a patient’s face to illuminate landmarks.

“I get the idea there, but the reason they are doing that is because they don’t have appropriate visualization within the anatomy, so we’ve developed a visualization system which performs both transcutaneous illumination and direct visualization within the sinus,” Gerrans said. “We’ve been able to deploy a small scope through the distal aspect of the balloon so we can see ahead into the sinus cavity, and we can use a sinuscope behind to see the placement of the balloon into the sinus.”

The technologies make up what Gerrans calls “the next-generation tool belt” for office-based sinuplasty, which he says is “cost effective and comparatively inexpensive compared to current procedures, which he hopes will help propel SinuGeniX over the coming years.

“It’s probably going to be 2 years of mass commercialization, competing in the market place and then working on the next generation. We’ve already got that in the queue. We’ve got some really exciting stuff that will follow on to this, but right now we want to get the core tool belt out there and do our best to serve the greater good,” Gerrans said.

The post Sanovas launches SinuGeniX sinus treatment subsidiary appeared first on MassDevice.

(Reuters) – These days the average researcher at Royal Philips (NYSE:PHG) is more likely to be a software developer than an product engineer, reflecting a transformation at the former Dutch conglomerate that its chief executive says will gather pace.

“It’s a huge shift,” Frans van Houten told Reuters, noting that around 60% of the healthcare technology company’s R&D staff are now focused on software.

“It could rise further. It will not go to 100%, because we will still make products, but you could easily see that the value-add comes more out of software than hardware.”

Philips has repositioned itself as a health business after spinning off lighting, which has freed up capacity for acquisitions such as last year’s $1.2 billion purchase of blood vessel imaging firm Volcano.

“M&A will play a more active role,” van Houten said during a visit to London, highlighting informatics, diagnostics, patient monitoring and homecare as areas for potential deals.

Philips is betting on a new era of connected healthcare as smart connected devices in hospitals and at home feed data to doctors, insurers and drugmakers.

It is not alone in targeting this convergence of health and technology, with traditional medtech groups like Medtronic striving to integrate disease care and newcomers, such as Google parent Alphabet, also investing heavily.

But van Houten believes Philips’ existing standing with consumers can give it an edge.

“Having a consumer brand helps us a lot. We will see more ambulatory care and there will be a lot of new ways to deliver healthcare … and that means consumerism is going to play a bigger role.”

The humble toothbrush may be a start. Philips already sells connected ones designed to encourage correct brushing in children and adults. In future, its toothbrushes could include a sensor to measure disease biomarkers in saliva.

At the other end of the spectrum, the group is developing integrated solutions for cancer, such as a single workstation combining genomics, pathology and radiology that can give medics a complete picture of tumors.

Philips’ full reinvention still has a little way to run.

A sale of lighting components business Lumileds to Chinese buyers was blocked earlier this year by the United States on security grounds, although van Houten said he still hoped to clinch a deal before the end of the year.

It also retains 71% of Philips Lighting, which van Houten said could take a few years to unwind.

The post From smart toothbrushes to cancer, Philips bets big on software appeared first on MassDevice.

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD November 2016


TOTAL 510(k)s THIS PERIOD   254                                     
TOTAL WITH SUMMARIES        241                                     
TOTAL WITH STATEMENTS        13


DEVICE: Quest Diagnostics HairCheck-DT (Cocaine)
Quest Diagnostics Incorporated    510(k) NO: K152232(Traditional)
ATTN: Lisa  Christo               PHONE NO : 913 5771784 
10101 Renner Blvd.                SE DECISION MADE: 18-NOV-16
Lenexa KS  66219-9275             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vonflex S
VERICOM CO., LTD.                 510(k) NO: K152615(Traditional)
ATTN: Myung-Hwan  Oh              PHONE NO : 82 31 4412881 
48, Toegyegongdan 1-gil           SE DECISION MADE: 03-NOV-16
Chuncheon-Si,   KR 200-944        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HYPNOSPAD
Somnics Inc.                      510(k) NO: K152660(Traditional)
ATTN: TSUNG-MIN  HSIEH            PHONE NO : 886 355 09623190 
5F , No.22, Sec. 2, Sheng Yi Road.SE DECISION MADE: 09-NOV-16
Hsinchu County  TW 30261          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable High Pressure Injector Syringe
WUXI YUSHOU MEDICAL APPLICANCES CO510(k) NO: K152906(Traditional)
ATTN: Wu  Feng                    PHONE NO : 86 510 83771274 
NO. 215 XIGANG ROAD, DONGBEITANG  SE DECISION MADE: 22-NOV-16
WUXI   CN 214191                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fingertip Pulse Oximeter A310
AMEMO INC                         510(k) NO: K153021(Traditional)
ATTN: HUA  XIE                    PHONE NO : 510 5099680 
1154 CADILLAC COURT               SE DECISION MADE: 22-NOV-16
MILPITAS CA  95035                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEMASORBPLUS Resorbable Hemostatic Bone Putty
ORTHOCON, INC.                    510(k) NO: K153317(Traditional)
ATTN: HOWARD L. SCHRAYER          PHONE NO : 609 9249510 
1 BRIDGE STREET, SUITE 121        SE DECISION MADE: 30-NOV-16
IRVINGTON NY  10533               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator
Diazyme Laboratories              510(k) NO: K153394(Traditional)
ATTN: Abhijit  Datta              PHONE NO : 858 4554762 
12889 Gregg Court                 SE DECISION MADE: 18-NOV-16
Poway CA  92064                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)
PROTECT U GUARD, LLC              510(k) NO: K153409(Abbreviated)
ATTN: Brent W. Laartz             PHONE NO : 813 8150530 
1840 MEASE DRIVE SUITE 319        SE DECISION MADE: 15-NOV-16
Safety Harbor FL  34695           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PathLoc-SI Joint Fusion System
L&K BIOMED Co., Ltd.              510(k) NO: K153656(Traditional)
ATTN: Yerim  An                   PHONE NO : 82 2 67171985 
#201, 202 16-25, Dongbaekjungang-rSE DECISION MADE: 14-NOV-16
Giheung-gu, Yongin-si  KR 446-916 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens, SynergEyes UltraHealth for Keratoconus (petrafocon A hem-larafilcon A) Hybrid Daily Wear Co 
Synergeyes, Inc.                  510(k) NO: K153714(Abbreviated)
ATTN: Karen   Kincade             PHONE NO : 760 4769410 
5927 PRIESTLY DR SUITE210         SE DECISION MADE: 15-NOV-16
CARLSBAD CA  92008                510(k) STATEMENT
                                                    

DEVICE: Disposal Lens Cleaning Sheath
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K153773(Traditional)
ATTN: TOSHIYUKI  NAKAJIMA         PHONE NO : 81 426 422694 
2951 ISHIKAWA-CHO                 SE DECISION MADE: 22-NOV-16
HACHIOJI-SHI  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Heyman Packing Applicator Set
VARIAN MEDICAL SYSTEMS, INC       510(k) NO: K160045(Traditional)
ATTN: PETER J. CORONADO           PHONE NO : 650 4246230 
3100 HANSEN WAY                   SE DECISION MADE: 17-NOV-16
PALO ALTO CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Charisma
Heraeus Kulzer, LLC (Mitsui Chemic510(k) NO: K160049(Traditional)
ATTN: Jamie  Cleveland            PHONE NO : 574 2995421 
4315 S. Lafayette Blvd            SE DECISION MADE: 15-NOV-16
South Bend IN  46614              510(k) STATEMENT
                                                    

DEVICE: rainbow Shine
GENOSS Co. Ltd.                   510(k) NO: K160079(Traditional)
ATTN: Byungsun  Kim               PHONE NO : 82 70 70988806 
1F Gyeonggi R&DB Center/226, 2F, GSE DECISION MADE: 10-NOV-16
Suwon-si  KR 443-270              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iCodeConnect
3B MEDICAL, INC.                  510(k) NO: K160127(Traditional)
ATTN: ALEX  LUCIO                 PHONE NO : 863 2266285 
799 Overlook Drive                SE DECISION MADE: 10-NOV-16
Winter Haven FL  33884            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC
HAGER & MEISINGER GMBH            510(k) NO: K160132(Traditional)
ATTN: Melanie   May               PHONE NO : 49 02131 2012292 
HANSEMANNSTRASSE 10               SE DECISION MADE: 21-NOV-16
NEUSS  DE 41468                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ABL90 FLEX PLUS
RADIOMETER MEDICAL APS            510(k) NO: K160153(Special)
ATTN: SOEREN   BOEGESTRAND        PHONE NO : 45 3 8273852 
AAKANDEVEJ 21                     SE DECISION MADE: 04-NOV-16
BROENSHOEJ  DK DK-2700            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X-MIND trium 
DE GOTZEN S.R.L.                  510(k) NO: K160166(Abbreviated)
ATTN: Olivier   Balouka           PHONE NO : 39 0331 376760 
VIA ROMA, 45                      SE DECISION MADE: 15-NOV-16
OLGIATE OLONA,  IT 21057          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intermittent Pneumatic Compression system
DaeSung Maref Co., Ltd            510(k) NO: K160180(Special)
ATTN: Jae-wha  Lee                PHONE NO : 82 31 4597211 
298-24, Gongdan-ro                SE DECISION MADE: 03-NOV-16
Gunpo-si  KR 15809                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sunmed Control Syringes
Sunny Medical Device (Shenzhen) Co510(k) NO: K160190(Traditional)
ATTN: James Qi Zhang              PHONE NO : 949 2168838 
56 Lehigh Aisle                   SE DECISION MADE: 10-NOV-16
Irvine CA  92612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VSTAAR AdjusteR
SPINAL ACOUSTICS, LLC             510(k) NO: K160278(Traditional)
ATTN: ALBERT A. TORRENCE          PHONE NO : 724 7755200 
640 FOURTH STREET                 SE DECISION MADE: 04-NOV-16
BEAVER PA  15009                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Sphygmomanometer
Guangdong Biolight Meditech Co., L510(k) NO: K160349(Traditional)
ATTN: Liang  Jin                  PHONE NO : 
Innovation First Road, Technical ISE DECISION MADE: 03-NOV-16
Zhuhai  CN 519085                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRIMAGARD Isolation Gown (AAMI PB70 Level 3)
PRIMED MEDICAL PRODUCTS INC.      510(k) NO: K160361(Traditional)
ATTN: RICHARD  R  ROY             PHONE NO : 1 780 4977600 
3RD FLOOR, 1259-91 ST SW.         SE DECISION MADE: 04-NOV-16
EDMONTON  CA T6X1E9               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter
Innovative Health, LLC.           510(k) NO: K160421(Traditional)
ATTN: Rafal  Chudzik              PHONE NO : 480 5256006 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 02-NOV-16
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PleurX Peritoneal Catheter System
CareFusion                        510(k) NO: K160437(Traditional)
ATTN: Tamara  Brey                PHONE NO : 847 3629485 
75 North Fairway Drive            SE DECISION MADE: 03-NOV-16
Vernon Hills IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MCP Bone Putty
BioStructures, LLC                510(k) NO: K160446(Traditional)
ATTN: John  Brunelle              PHONE NO : 949 5531717 
1201 Dove Street, Suite 470       SE DECISION MADE: 07-NOV-16
Newport Beach CA  92660           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Calprest NG
EUROSPITAL S.P.A.                 510(k) NO: K160447(Traditional)
ATTN: Claudia  Brandolin          PHONE NO : 39 040 89971 
VIA FLAVIA 122                    SE DECISION MADE: 10-NOV-16
TRIESTE  IT 34147                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vivo 60
BREAS MEDICAL AB                  510(k) NO: K160481(Traditional)
ATTN: Albert   Cefalo             PHONE NO : 617 3566289 
FORETAGSVAGEN 1                   SE DECISION MADE: 09-NOV-16
MOLNLYCKE VASTRA GOTALANDS LAN  SE510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Pulse Stimulator
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K160508(Traditional)
ATTN: Lei   Chen                  PHONE NO : 86 108 8798300 6020
NO.9 SHUANGYUAN ROAD, BADACH HI-TESE DECISION MADE: 21-NOV-16
Beijing  CN 100041                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HardyCHROM ESBL
HARDY DIAGNOSTICS                 510(k) NO: K160512(Traditional)
ATTN: ANDRE  HSIUNG               PHONE NO : 805 3462766 
1430 WEST MCCOU LANE              SE DECISION MADE: 15-NOV-16
SANTA MARIA CA  93455             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff
SHENZHEN MED-LINK ELECTRONICS TECH510(k) NO: K160530(Traditional)
ATTN: Mina  Cheng                 PHONE NO : 86 755 61120299 
4TH FL, BLDG A, YINGTAILONG INDUSTSE DECISION MADE: 28-NOV-16
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Greiner Holdex
GREINER BIO-ONE NA INC.           510(k) NO: K160532(Traditional)
ATTN: MANFRED  ABEL               PHONE NO : 704 2617823 
4238 CAPITAL DRIVE                SE DECISION MADE: 03-NOV-16
MONROE NC  28110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GAP ENDO-EXO MEDULLARY SYSTEM
PEGA MEDICAL INC.                 510(k) NO: K160545(Traditional)
ATTN: Ariel  R.  Dujovne          PHONE NO : 1 450 6885144 
1111 AUTOROUTE CHOMEDEY           SE DECISION MADE: 23-NOV-16
LAVAL  CA H7W 5J8                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RAPIDO HOLLOW-FIBRE DIALYZERS
BELLCO Srl                        510(k) NO: K160558(Traditional)
ATTN: Giuseppe  Tomasini          PHONE NO : 0039 0535 29323 
via Camurana 1                    SE DECISION MADE: 18-NOV-16
Mirandola  IT 41037               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Boosting Catheter
QXMEDICAL, LLC                    510(k) NO: K160561(Traditional)
ATTN: FERNANDO   DI CAPRIO        PHONE NO : 651 8422050 
2820 PATTON ROAD                  SE DECISION MADE: 02-NOV-16
ROSEVILLE MN  55113               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TroClose1200
GORDIAN SURGICAL LTD.             510(k) NO: K160564(Traditional)
ATTN: ZVI  PEER                   PHONE NO : 972 72 2607079 
17TH TCHELET ST.                  SE DECISION MADE: 17-NOV-16
KARMIEL  IL 2161401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MRWire Guide Wire
NANO4IMAGING GMBH                 510(k) NO: K160594(Traditional)
ATTN: CHRISTOPH R. MANEGOLD       PHONE NO : 49 241 56528261 
PAUWELSSTR. 17                    SE DECISION MADE: 22-NOV-16
AACHEN  DE 52074                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator
PMS Medikal Ambalaj Sanayi ve Tica510(k) NO: K160595(Traditional)
ATTN: Derya  Dikici               PHONE NO : 90 324 2387042 
Karaduvar Mah Serbest Bolge, 11 caSE DECISION MADE: 18-NOV-16
Mersin  TR 33020                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline ENFit Syringe
Medline Industries, Inc.          510(k) NO: K160642(Traditional)
ATTN: Stephanie  Blair            PHONE NO : 847 6433690 
One Medline Place                 SE DECISION MADE: 29-NOV-16
Mundelein IL  60060               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CorSens
CorSens Medical Ltd.              510(k) NO: K160656(Traditional)
ATTN: Yoram  Levy                 PHONE NO : 972 3 6070306 
3 Azrieli Center Triangular Tower SE DECISION MADE: 21-NOV-16
Tel Aviv  IL 6702301              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)
EVOLUTION SPINE, LLC              510(k) NO: K160663(Traditional)
ATTN: Ashton  Kouzbari            PHONE NO : 214 6828536 
4225 OFFICE PARKWAY               SE DECISION MADE: 16-NOV-16
Dallas TX  75204                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CONTOUR NEXT ONE Blood Glucose Monitoring System
ASCENSIA DIABETES CARE            510(k) NO: K160682(Traditional)
ATTN: Roger  Sonnenburg           PHONE NO : 574 2563441 
430 S. BEIGER ST.                 SE DECISION MADE: 17-NOV-16
Mishawaka IN  46544               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,
Y. JACOBS MEDICAL, INC            510(k) NO: K160705(Traditional)
ATTN: HUI JUN PARK                PHONE NO : 82 254 60715 
6F SANGKYUNG BLDG. 669 SEOLLEUNG-RSE DECISION MADE: 23-NOV-16
SEOUL  KR 135-830                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vital Sync Informatics Manager & Virtual Patient Monitoring Platform
COVIDIEN                          510(k) NO: K160718(Traditional)
ATTN: Timothy  Holwick            PHONE NO : 303 3052345 
6135 Gunbarrel Avenue             SE DECISION MADE: 14-NOV-16
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Carriere Motion Clear Class II
ORTHO ORGANIZERS, INC.            510(k) NO: K160720(Traditional)
ATTN: COLLEEN  BOSWELL            PHONE NO : 760 4488730 
1822 ASTON AVENUE                 SE DECISION MADE: 28-NOV-16
CARLSBAD CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CARDIOLINE touchECG
CARDIOLINE S.p.A                  510(k) NO: K160746(Traditional)
ATTN: Emanuele  Ercoli            PHONE NO : 039 0463 850125 
VIA LINZ 19-20-21                 SE DECISION MADE: 02-NOV-16
Z.I. SPINI DI GARDOLO  IT 38121   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DW-1C
DONGWON MEDICAL CO., LTD.         510(k) NO: K160761(Traditional)
ATTN: Gil  Haeng Lee              PHONE NO : 82 624 306521 
201-HO, 35, SAAM-RO 340BEON-GIL GWSE DECISION MADE: 22-NOV-16
Gwangju  KR 62328                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set
DIAZYME LABORATORIES              510(k) NO: K160762(Traditional)
ATTN: ABHIJIT  DATTA              PHONE NO : 858 4554762 
12889 GREGG COURT                 SE DECISION MADE: 21-NOV-16
POWAY CA  92064                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RODO Abutment System
RODO MEDICAL, INC                 510(k) NO: K160786(Traditional)
ATTN: Michael   Parsons           PHONE NO : 408 2457636 
690 SARATOGA AVE., SUITE 100      SE DECISION MADE: 21-NOV-16
SAN JOSE CA  95129                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AmorChem Titanium Porous Fixation Device
AmorChem Holdings, Inc.           510(k) NO: K160791(Traditional)
ATTN: KEVIN  MCBRIDE              PHONE NO : 514 8495451 
1, Westmount Square               SE DECISION MADE: 15-NOV-16
Montreal  CA H3Z 2P9              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DuoCem
COLTENE/WHALEDENT AG              510(k) NO: K160800(Traditional)
ATTN: Silke   Wallaschek          PHONE NO : 0041 71 7575852 
FELDWIESENSTR. 20                 SE DECISION MADE: 16-NOV-16
ALTSTATTEN  CH 9450               510(k) STATEMENT
                                                    

DEVICE: Well Lead Extraction Bag
WELL LEAD MEDICAL CO., LTD.       510(k) NO: K160801(Traditional)
ATTN: HAN GUANG YUAN              PHONE NO : 86 20 84758878 
C-4 # JINHU INDUSTRIAL ESTATE, HUASE DECISION MADE: 29-NOV-16
GUANGZHOU  CN 511434              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: U&U Enteral Syringe
U&U MEDICAL TECHNOLOGY CO.,LTD    510(k) NO: K160855(Traditional)
ATTN: BLACK   WANG                PHONE NO : 0086 1390 2471751 
DONGZHOU VILLAGE, HENGYSHANQIAO   SE DECISION MADE: 22-NOV-16
CHANGZHOU   CN 213119             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PolyPlex Wound Dressing
GLOBAL HEALTH SOLUTIONS, LLC      510(k) NO: K160872(Traditional)
ATTN: Bradley   Burnam            PHONE NO : 706 8441025 
1360 REDMOND CIRCLE               SE DECISION MADE: 23-NOV-16
Rome GA  30165                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tablo Console
OUTSET MEDICAL, INC.              510(k) NO: K160881(Traditional)
ATTN: LESLIE  TRIGG               PHONE NO : 650 2694483 
1830 BERING DRIVE                 SE DECISION MADE: 15-NOV-16
SAN JOSE CA  95112                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CXI Support Catheter
COOK INCORPORATED                 510(k) NO: K160884(Special)
ATTN: Daniel J. Corbin            PHONE NO : 812 3392235 104018
750 DANIELS WAY                   SE DECISION MADE: 22-NOV-16
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Initia Total Hip System & BIOCERAM AZUL(R) HEAD
KYOCERA Medical Corporation       510(k) NO: K160895(Traditional)
ATTN: Cheryl  Hastings            PHONE NO : 574 5274220 
Uemura Nissei Bldg., 3-3-31 MiyahaSE DECISION MADE: 01-NOV-16
Yodogawa-ku  JP 532-0003          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant
CS Medical LLC                    510(k) NO: K160921(Traditional)
ATTN: Kendall  Ashe               PHONE NO : 919 2559472 
2179 East Lyon Station Road       SE DECISION MADE: 03-NOV-16
Creedmoor NC  27522               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REDAPT Anteverted Cemented Liner
SMITH & NEPHEW, INC.              510(k) NO: K160923(Traditional)
ATTN: KIM  PHAN                   PHONE NO : 901 8003175 
7135 GOODLETT FARMS PARKWAY       SE DECISION MADE: 17-NOV-16
CORDOVA TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Amendia Interbody Fusion Devices
AMENDIA, INC.                     510(k) NO: K160924(Traditional)
ATTN: Bruce   Hooper              PHONE NO : 877 7553329 
1755 WEST OAK PARKWAY             SE DECISION MADE: 08-NOV-16
MARIETTA GA  30062                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Discovery NM 750b Bopsy
GE Healthcare                     510(k) NO: K160933(Traditional)
ATTN: Efrat  Hartog-David         PHONE NO : 972 4 8563666 805
4 Hayozma Street                  SE DECISION MADE: 18-NOV-16
Tirat Hacarmel  IL 30200          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Masimo Disposable Transflectance Forehead Sensor
Masimo Corporation                510(k) NO: K160940(Traditional)
ATTN: Marguerite  Thomlinson      PHONE NO : 949 2977000 
52 Discovery                      SE DECISION MADE: 23-NOV-16
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xsert Lumbar Expandable Interbody System
X-SPINE SYSTEMS, INC.             510(k) NO: K160959(Traditional)
ATTN: KRISS  ANDERSON             PHONE NO : 937 8478400 
452 ALEXANDERSVILLE RD.           SE DECISION MADE: 17-NOV-16
MIAMISBURG OH  45342              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Inclusive Abutments
PRISMATIK DENTALCRAFT, INC.       510(k) NO: K160979(Traditional)
ATTN: SHELLY  HARRIS              PHONE NO : 949 4402629 
2212 DUPONT DRIVE, SUITE P        SE DECISION MADE: 04-NOV-16
IRVINE CA  92612                  510(k) STATEMENT
                                                    

DEVICE: SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive
Adhezion Biomedical, LLC          510(k) NO: K161011(Traditional)
ATTN: Richard  Jones              PHONE NO : 610 2417191 
One Meridian Boulevard, Suite 1B02SE DECISION MADE: 08-NOV-16
Wyomissing PA  19610              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InnoSEAL Hemostatic Pad
InnoTherapy Inc.                  510(k) NO: K161013(Traditional)
ATTN: Moon Sue Lee                PHONE NO : 82 2 69591338 
Ace Hightechcity2,25, Seonyu-ro 13SE DECISION MADE: 29-NOV-16
Seoul  KR 07282                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cadwell AmpliScan
Cadwell Industries, Inc.          510(k) NO: K161027(Traditional)
ATTN: John  Cadwell               PHONE NO : 509 7356481 
909 N. Kellog St.                 SE DECISION MADE: 08-NOV-16
Kennewick WA  99336               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves Flock-Lined, Black Color
SHEN WEI (USA), INC.              510(k) NO: K161074(Traditional)
ATTN: CHERYL  BAILEY-KROLL        PHONE NO : 510 4298692 
33278 CENTRAL AVE., SUITE 102     SE DECISION MADE: 17-NOV-16
UNION CITY CA  94587              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FONA Pan/Ceph
FONA SRL                          510(k) NO: K161131(Traditional)
ATTN: ELISA  GUSBERTI             PHONE NO : 39 02 45712171 
VIA GALILEO GALILEI 11            SE DECISION MADE: 03-NOV-16
ASSAGO  IT 20090                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitrea CT Dual Energy Image View
VITAL IMAGES, INC.                510(k) NO: K161157(Traditional)
ATTN: Alexis  Erazo               PHONE NO : 952 4879774 
5850 OPUS PARKWAY SITE 300        SE DECISION MADE: 03-NOV-16
Minnetonka MN  55343-4414         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nanova Interference Screw
NANOVA BIOMATERIALS INC.          510(k) NO: K161174(Traditional)
ATTN: ANDREW  RITTS               PHONE NO : 573 8756682 
3806 MOJAVE CT                    SE DECISION MADE: 03-NOV-16
COLUMBIA MO  65202                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Renovo Life Small Bone IM Nail System
Renovo Life LLC                   510(k) NO: K161254(Traditional)
ATTN: Harold  Crowder             PHONE NO : 704 2244136 
1104 Spruce Street                SE DECISION MADE: 07-NOV-16
Belmont NC  28012                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRIGEN Low Profile Bone Screws
SMITH & NEPHEW, INC.              510(k) NO: K161264(Special)
ATTN: ALLISON  CHAN               PHONE NO : 901 3991098 
1450 E. BROOKS ROAD               SE DECISION MADE: 23-NOV-16
MEMPHIS TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ConvertX Nephroureteral Stent System
BRIGHTWATER MEDICAL               510(k) NO: K161277(Traditional)
ATTN: BOB  SMOUSE                 PHONE NO : 1 650 2108100 
816 W. BENNETT CT.                SE DECISION MADE: 22-NOV-16
DUNLAP IL  61525                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LenSX Laser System
ALCON LABORATORIES, INC.          510(k) NO: K161288(Traditional)
ATTN: JAMES  ARGANDA              PHONE NO : 949 5057038 
20511 LAKE FOREST DR              SE DECISION MADE: 16-NOV-16
LAKE FOREST CA  92630             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solution Set for Epidural Use
BAXTER HEALTHCARE CORPORATION     510(k) NO: K161323(Third Party - Traditional)
ATTN: Tiffany   Lin               PHONE NO : 224 2704343 
32650 N. WILSON ROAD              SE DECISION MADE: 30-NOV-16
ROUND LAKE IL  60073              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: LipiFlow Thermal Pulsation System
TEARSCIENCE, INC.                 510(k) NO: K161357(Special)
ATTN: Christy   Coleman           PHONE NO : 919 4594815 
5151 MCCRIMMON PARKWAY SUITE 250  SE DECISION MADE: 04-NOV-16
MORRISVILLE NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Durepair Dura Regeneration Matrix
Medtronic Neurosurgery            510(k) NO: K161370(Traditional)
ATTN: Manas  Lele                 PHONE NO : 805 5718956 
125 Cremona Drive                 SE DECISION MADE: 02-NOV-16
Goleta CA  93117                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nunchaku
FCI (FRANCE CHIRURGIE INSTRUMENTAT510(k) NO: K161373(Traditional)
ATTN: THIERRY  FETICK             PHONE NO : 33 153 989898 
20-22 RUE LOUIS ARMAND            SE DECISION MADE: 03-NOV-16
PARIS  FR 75015                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: joimax Electrosurgical Instruments
JOIMAX GMBH                       510(k) NO: K161378(Traditional)
ATTN: WOLFGANG  RIES              PHONE NO : 49 072 1255140 
AMALIENBADSTR. 41 RAUMFABRIK 61   SE DECISION MADE: 02-NOV-16
KARLSRUHE  DE 76227               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
ALCON LABORATORIES, INC.          510(k) NO: K161391(Traditional)
ATTN: Sherri  Lakota              PHONE NO : 817 6155472 
6201 SOUTH FREEWAY                SE DECISION MADE: 30-NOV-16
FORT WORTH TX  76134-2099         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Compass Cast and MAP
CENTURION MEDICAL PRODUCTS CORPORA510(k) NO: K161408(Traditional)
ATTN: MATTHEW K. PRICE            PHONE NO : 517 5465400 1135
100 CENTURION WAY                 SE DECISION MADE: 22-NOV-16
WILLIAMSTON MI  48895             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Synthes MAXFRAME Multi-Axial Correction System
SYNTHES USA, LLC                  510(k) NO: K161417(Traditional)
ATTN: STACEY  BONNELL             PHONE NO : 610 7195895 
1301 GOSHEN PARKWAY               SE DECISION MADE: 10-NOV-16
WEST CHESTER PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SimplECG
Nanowear Inc.                     510(k) NO: K161431(Traditional)
ATTN: Venkatesh  Varadan          PHONE NO : 718 6374815 
53 Boerum Place Suite 3F          SE DECISION MADE: 30-NOV-16
Brooklyn NY  11201                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Insulia Diabetes Management Companion
VOLUNTIS S.A.                     510(k) NO: K161433(Traditional)
ATTN: RAFFI  KRIKORIAN            PHONE NO : 33 141 383920 
58, AVENUE DE WAGRAM              SE DECISION MADE: 09-NOV-16
Paris  FR 75017                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Temporary Snap Abutment
Nobel Biocare AB                  510(k) NO: K161435(Traditional)
ATTN: Charlemagne  Chua           PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 22-NOV-16
Goteborg  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Genesys Spine Apache® Anterior Lumbar Interbody Fusion System
GENESYS SPINE                     510(k) NO: K161438(Traditional)
ATTN: BRIAN  BERGERON             PHONE NO : 512 3817071 
1250 CAPITAL OF TEXAS OF HIGHWAY SSE DECISION MADE: 08-NOV-16
AUSTIN TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Propeller Sensor Model 2015-E
Reciprocal Labs Corporation       510(k) NO: K161454(Traditional)
ATTN: Taylor  Mahan-Rudolph       PHONE NO : 608 2510470 
634 W. Main Street, Suite 102     SE DECISION MADE: 01-NOV-16
Madison WI  53703                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XEN Glaucoma Treatment System
Allergan, Inc.                    510(k) NO: K161457(Traditional)
ATTN: Barbara A. Niksch           PHONE NO : 949 4500250 236
26970 Aliso Viejo Parkway, Suite 2SE DECISION MADE: 21-NOV-16
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Walk-O2-Bout
ESSEX INDUSTRIES, INC.            510(k) NO: K161472(Traditional)
ATTN: RUSS  JACOBSMEYER           PHONE NO : 314 3388723 
7700 GRAVOIS                      SE DECISION MADE: 18-NOV-16
ST. LOUIS MO  63123               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: YO Home Sperm Test
MEDICAL ELECTRONIC SYSTEMS, LTD   510(k) NO: K161493(Traditional)
ATTN: MARCIA   DEUTSCH            PHONE NO : 972 463 73981 
ALON HATAVOR ST.20  ZONE 6        SE DECISION MADE: 08-NOV-16
CAESAREA IND. PARK  IL 38900      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
Siemens Healthcare Diagnostics, In510(k) NO: K161494(Traditional)
ATTN: Laura J. Duggan             PHONE NO : 302 6317654 
500 GBC Drive, PO Box 6101 MS 514 SE DECISION MADE: 15-NOV-16
Newark DE  19711                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: eUnity
Client Outlook Inc.               510(k) NO: K161515(Special)
ATTN: Christie  Eby               PHONE NO : 519 3423049 206
103 Bauer Place, Suite #3         SE DECISION MADE: 15-NOV-16
Waterloo  CA N2L6B5               510(k) STATEMENT
                                                    

DEVICE: MatrixRIB Fixation System
SYNTHES (USA) PRODUCTS LLC        510(k) NO: K161590(Traditional)
ATTN: THOMAS  SHEA                PHONE NO : 610 7195679 
1301 GOSHEN PARKWAY               SE DECISION MADE: 03-NOV-16
WEST CHESTER PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Persona Partial Knee System
BIOMET, INC.                      510(k) NO: K161592(Traditional)
ATTN: Nicole  J.  Meredith        PHONE NO : 574 3773718 
56 EAST BELL DR.                  SE DECISION MADE: 03-NOV-16
WARSAW IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyber Medical BioTy® Nanotopography Trauma Screw
TYBER MEDICAL LLC                 510(k) NO: K161597(Traditional)
ATTN: MARK F. SCHENK              PHONE NO : 610 84906045 
89 HEADQUARTERS PLAZA NORTH #1464 SE DECISION MADE: 16-NOV-16
MORRISTOWN NJ  07960              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EXPRT Revision Hip System
Encore Medical, L.P.              510(k) NO: K161610(Traditional)
ATTN: TEFFANY  HUTTO              PHONE NO : 512 8346255 
9800 METIRC BLVD                  SE DECISION MADE: 09-NOV-16
AUSTIN TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anatomical Shoulder Domelock Dome centric
ZIMMER GMBH                       510(k) NO: K161620(Traditional)
ATTN: ROBERTO  TOMMASINI          PHONE NO : 41 58 8548264 
SULZERALLEE 8                     SE DECISION MADE: 01-NOV-16
WINTERTHUR  CH 8404               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
B. Braun Medical Inc.             510(k) NO: K161623(Traditional)
ATTN: Nancy  Skocypec             PHONE NO : 610 2664962___ 
901 Marcon Blvd                   SE DECISION MADE: 10-NOV-16
Allentown PA  18109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MicrO2 OSA Device with Micro-Recorder
MICRODENTAL, Inc.                 510(k) NO: K161624(Traditional)
ATTN: David  Kuhns                PHONE NO : 925 8038643 
5601 Arnold Rd.                   SE DECISION MADE: 07-NOV-16
Dublin CA  94568                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JAS Pulse(TM) Ultrasonic Therapy
Bonutti Research, Inc.            510(k) NO: K161628(Abbreviated)
ATTN: Patrick G. Balsmann         PHONE NO : 217 3423412 5106
P.O. Box 1367                     SE DECISION MADE: 10-NOV-16
Effingham IL  62401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPS CaseDesigner
NOBEL BIOCARE AB                  510(k) NO: K161634(Traditional)
ATTN: CHARLEMAGNE  CHUA           PHONE NO : 714 2824800 7830
VASTRA HAMNGATAN 1                SE DECISION MADE: 10-NOV-16
GOTEBORG  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lipogems System
Lipogems International SpA        510(k) NO: K161636(Traditional)
ATTN: CARLO  RUSSO                PHONE NO : 39 02 37072408 
viale Bianca Maria 24             SE DECISION MADE: 04-NOV-16
Milano  IT 20129                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPEEDTRAP Graft Preparation System
MEDOS INTERNATIONAL SARL          510(k) NO: K161638(Traditional)
ATTN: Jeffrey  Dzialo             PHONE NO : 
CHEMIN-BLANC 38                   SE DECISION MADE: 07-NOV-16
LE LOCLE NEUCHATEL  CH 2400       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
DIAZYME LABORATORIES              510(k) NO: K161646(Traditional)
ATTN: ABHIJIT  DATTA              PHONE NO : 858 4554762 
12889 GREGG COURT                 SE DECISION MADE: 04-NOV-16
POWAY CA  92130                   510(k) STATEMENT
                                                    

DEVICE: Virtu C Spinal Implant System
Met 1 Technologies, LLC           510(k) NO: K161649(Traditional)
ATTN: Dan  Gerbec                 PHONE NO : 915 3010834 
154 N. Festival Dr., Ste. F       SE DECISION MADE: 09-NOV-16
El Paso TX  79912                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VLP Wrist Fracture System
SMITH & NEPHEW, INC.              510(k) NO: K161665(Traditional)
ATTN: SAMANTHA  STAUBACH          PHONE NO : 901 3996132 
1450 BROOKS ROAD                  SE DECISION MADE: 15-NOV-16
MEMPHIS TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lucid Q-PTP / HWA 55
BISON MEDICAL CO., LTD            510(k) NO: K161670(Traditional)
ATTN: SUN  WO                     PHONE NO : 82 286 57121 
ACE HIGH-END TOWER 6, 1801 BEOTKKOSE DECISION MADE: 02-NOV-16
GUEM CHEN GU  KR 153-789          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LacriPro Punctum Plug
LACRIMEDICS, INC.                 510(k) NO: K161673(Traditional)
ATTN: REBECCA C. DUTTON           PHONE NO : 253 9640360 
2620 WILLIAMSON PLACE NW, SUITE 11SE DECISION MADE: 18-NOV-16
DUPONT WA  98245                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diode Laser Therapy Machine
BEIJING ADSS DEVELOPMENT CO., LTD 510(k) NO: K161692(Traditional)
ATTN: GAO  YURONG                 PHONE NO : 86 10 83625120 
F6, XIANDO BLDG., JINYUAN RD. 36, SE DECISION MADE: 16-NOV-16
BEIJING  CN 102628                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5
AAP IMPLANTATE AG                 510(k) NO: K161696(Traditional)
ATTN: RENI  SCHALLER              PHONE NO : 49 307 50190 
LORENZWEG 5                       SE DECISION MADE: 23-NOV-16
BERLIN  DE 12099                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters
STERILMED, INC.                   510(k) NO: K161700(Traditional)
ATTN: Reuben  Lawson              PHONE NO : 949 7898545 
5010 CHESHIRE PARKWAY STE. 2      SE DECISION MADE: 21-NOV-16
Plymouth MN  55446                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer
AAP IMPLANTATE AG                 510(k) NO: K161703(Traditional)
ATTN: RENI  SCHALLER              PHONE NO : 49 307 50190 
LORENZWEG 5                       SE DECISION MADE: 04-NOV-16
BERLIN  DE 12099                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arm automatic blood pressure monitor
SHENZHEN PUMP MEDICAL SYSTEM CO., 510(k) NO: K161708(Special)
ATTN: XIE  QIONGYU                PHONE NO : 086 0755 26710795 
2/F, M-7 SINOSTEEL BUILDING, MAQUESE DECISION MADE: 22-NOV-16
NANSHAN DISTRICT, SHENZHEN  CN 518510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-contact Forehead Thermometer
Shenzhen Dongdixin Technology Co.,510(k) NO: K161735(Traditional)
ATTN: Siping  Yuan                PHONE NO : 086 075 527652471 
No. 3 Building Xilibaimang XushengSE DECISION MADE: 17-NOV-16
Shenzhen  CN 518108               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K161738(Traditional)
ATTN: PAUL  LIU                   PHONE NO : 886 2 66258188 
6F, NO.127, WUGONG 2ND RD., WUGU DSE DECISION MADE: 10-NOV-16
NEW TAIPEI CITY  TW 24888         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: D-SPECT Scanner, D-SPECT L Scanner
Spectrum Dynamics Medical Ltd     510(k) NO: K161740(Traditional)
ATTN: Igor  Naroditsky            PHONE NO : 972 54 4384386 
22 Bareket St                     SE DECISION MADE: 04-NOV-16
Caesarea  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
Tornier, Inc.                     510(k) NO: K161742(Traditional)
ATTN: Laurie  Lewandowski         PHONE NO : 612 7704038 
10801 Nesbitt Avenue South        SE DECISION MADE: 15-NOV-16
Bloomington MN  55340             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5
aap Implantate AG                 510(k) NO: K161747(Traditional)
ATTN: Reni  Schaller              PHONE NO : 0049 30 75019193 
Lorenzweg 5                       SE DECISION MADE: 22-NOV-16
Berlin  DE D-12099                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hoffman LRF System
STRYKER GMBH                      510(k) NO: K161753(Traditional)
ATTN: PAUL  NELSON                PHONE NO : 201 8315691 
325 CORPORATE DRIVE               SE DECISION MADE: 15-NOV-16
MAHWAH NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device
Smith & Nephew, Inc.              510(k) NO: K161763(Traditional)
ATTN: Bradley  Heil               PHONE NO : 901 3996339 
150 Minuteman Rd.                 SE DECISION MADE: 22-NOV-16
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LUCAS 3 Chest Compression System
Jolife AB                         510(k) NO: K161768(Traditional)
ATTN: Malin  Melander             PHONE NO : 46 46 2865000 
Scheelevagen 17, Ideon Science ParSE DECISION MADE: 09-NOV-16
Lund  SE 223 70                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lenstec LC Injection system
LENSTEC INC.                      510(k) NO: K161776(Traditional)
ATTN: JIMMY  CHACKO               PHONE NO : 727 5712272 
1765 COMMERCE AVE.N.              SE DECISION MADE: 29-NOV-16
ST. PETERSBURG FL  33716          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ToeTac™ 10° Hammertoe Fixation System
RESTORE SURGICAL LLC DBA INSTRATEK510(k) NO: K161778(Traditional)
ATTN: JEFF  SEAVEY                PHONE NO : 281 8908020 
15200 MIDDLEBROOK DR., SUITE G    SE DECISION MADE: 22-NOV-16
HOUSTON TX  77058                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter
MedSource International, LLC      510(k) NO: K161779(Traditional)
ATTN: Laura  Riggen               PHONE NO : 952 2418325 
401 Norex Drive                   SE DECISION MADE: 03-NOV-16
Chaska MN  55318                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Univers Revers Shoulder Prosthesis System
ARTHREX, INC.                     510(k) NO: K161782(Traditional)
ATTN: David L Rogers              PHONE NO : 239 6435553 71924
1370 CREEKSIDE BLVD.              SE DECISION MADE: 21-NOV-16
NAPLES FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM ESSENZA
Siemens Medical Solutions USA, Inc510(k) NO: K161795(Special)
ATTN: Cordell L. Fields           PHONE NO : 610 4486469 
65 Valley Stream Parkway          SE DECISION MADE: 18-NOV-16
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NNR06 Multi-Purpose Solution
Bausch & Lomb Incorporated        510(k) NO: K161819(Traditional)
ATTN: Glenn  Davies               PHONE NO : 585 3388215 
1400 North Goodman Street         SE DECISION MADE: 25-NOV-16
Rochester NY  14609               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set
Immunodiagnostic Systems Ltd      510(k) NO: K161831(Traditional)
ATTN: Mick  Henderson             PHONE NO : 440 191 5190660 
10 Didcot Way, Boldon Business ParSE DECISION MADE: 15-NOV-16
Boldon  GB NE35 9PD               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: One Drop Blood Glucose Monitoring System
AgaMatrix, Inc.                   510(k) NO: K161834(Special)
ATTN: David  Olsen                PHONE NO : 603 8934191 
7C Raymond Ave.                   SE DECISION MADE: 30-NOV-16
Salem NH  03079                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StatStrip Xpress Glucose Hospital Meter System
Nova Biomedical Corporation       510(k) NO: K161856(Special)
ATTN: Paul W. MacDonald           PHONE NO : 781 6473700 
200 Prospect Street               SE DECISION MADE: 15-NOV-16
Waltham MA  02454                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ThermoPro
Zimmer MedizinSysteme GmbH        510(k) NO: K161862(Traditional)
ATTN: Armin  Petraschka           PHONE NO : 49 731 9761140 
Junkersstrasse 9                  SE DECISION MADE: 14-NOV-16
Neu-Ulm  DE 89231                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)
Stryker GmbH                      510(k) NO: K161863(Traditional)
ATTN: Saad  Attiyah               PHONE NO : 201 8315655 
Bohnackerweg 1                    SE DECISION MADE: 23-NOV-16
2545 Selzach  CH CH 2545          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pacel Flow Directed Pacing Catheter
St. Jude Medical                  510(k) NO: K161873(Traditional)
ATTN: Blair  Schwartz             PHONE NO : 651 7562706 
14901 DeVeau Place                SE DECISION MADE: 22-NOV-16
Minnetonka MN  55345              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HC Primer
Shofu Dental Corporation          510(k) NO: K161891(Traditional)
ATTN: Mauro  Malzyner             PHONE NO : 760 7363277 
1225 Stone Drive                  SE DECISION MADE: 21-NOV-16
San Marcos CA  92078              510(k) STATEMENT
                                                    

DEVICE: Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge
CHANGZHOU XIN NENG YUAN MEDICAL ST510(k) NO: K161905(Traditional)
ATTN: Boping  Ma                  PHONE NO : 86 519 88830515 
NO.51, SHUISHAN RD, ZHONGLOU ECONOSE DECISION MADE: 17-NOV-16
Changzhou  CN 213023              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IQvitals Zone
Midmark Corporation               510(k) NO: K161909(Traditional)
ATTN: Asad  Abu-Tarif             PHONE NO : 800 6248950 
690 Knox Street, Suite 100        SE DECISION MADE: 17-NOV-16
Torrance CA  90502                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AOS Small Fragment Plating System
ADVANCED ORTHOPAEDIC  SOLUTIONS, I510(k) NO: K161913(Special)
ATTN: ALEX  BHASKARLA             PHONE NO : 310 5339966 
3203 KASHIWA STREET               SE DECISION MADE: 04-NOV-16
TORRANCE CA  90505                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SwiftNINJA Microcatheter
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K161921(Traditional)
ATTN: LUKE  MEIDELL               PHONE NO : 801 2084623 
1600 WEST MERIT PARKWAY           SE DECISION MADE: 04-NOV-16
SOUTH JORDAN UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink
Terang Nusa Sdn Bhd               510(k) NO: K161932(Traditional)
ATTN: Robert  Hill                PHONE NO : 0060 977 47171 
1 Jalan 8, Pengkalan Chepa 2, InduSE DECISION MADE: 28-NOV-16
Kota Bharu  MY 16100              510(k) STATEMENT
                                                    

DEVICE: Avance Foam Dressing Kit - XL
MOLNLYCKE HEALTH CARE, US LLC     510(k) NO: K161935(Traditional)
ATTN: MEGAN  BEVILL               PHONE NO : 470 3750049 
5550 PEACHTREE PARKWAY,  SUITE 500SE DECISION MADE: 04-NOV-16
NORCROSS GA  30092                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avance Abdominal Dressing Kit
Molnlycke Health Care US, LLC     510(k) NO: K161939(Traditional)
ATTN: Megan  Bevill               PHONE NO : 470 3750049 
5550 Peachtree Parkway, Suite 500 SE DECISION MADE: 17-NOV-16
Norcross GA  30092                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
SHANDONG BAISHENG MEDICAL PRODUCTS510(k) NO: K161944(Traditional)
ATTN: CECILY  SHENG               PHONE NO : 86 536 7510508 
11 Longshan Rd, Wolong Industy ParSE DECISION MADE: 21-NOV-16
Linqu  CN 262600                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avance Gauze Dressing Kits
MOLNLYCKE HEALTH CARE, US LLC     510(k) NO: K161948(Traditional)
ATTN: MEGAN  BEVILL               PHONE NO : 470 3750049 
5550 PEACHTREE PARKWAY, SUITE 500 SE DECISION MADE: 03-NOV-16
NORCROSS GA  30092                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UltraShape System
Syneron Medical Ltd.              510(k) NO: K161952(Traditional)
ATTN: Ruthie  Amir                PHONE NO : 972 73 2442200 
Tavor Building, Industrial Zone, PSE DECISION MADE: 07-NOV-16
Yokneam Illit  IL 20692           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: W&H Implantmed SI-1015 incl. Accessories
W&H DENTALWERK BURMOOS GMBH       510(k) NO: K161957(Traditional)
ATTN: ANJA  LINDNER               PHONE NO : 0043 6274 6236397 
IGNAZ-GLASER-STRABE 53            SE DECISION MADE: 23-NOV-16
BUERMOOS  AT 5111                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VAMP Venous/Arterial Blood Management Protection System
Edwards Lifesciences LLC          510(k) NO: K161962(Traditional)
ATTN: Jennifer  Wilbur            PHONE NO : 949 7564436 
One Edwards Way                   SE DECISION MADE: 28-NOV-16
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MicrUs
TELEMED                           510(k) NO: K161968(Traditional)
ATTN: Yury  Sokolov               PHONE NO : 370 5 2106272 
Dariaus ir Gireno str.42          SE DECISION MADE: 03-NOV-16
Vilnius  LT LT-02189              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SLENDERTONE® Connect Abs, Type 570
Bio-Medical Research Ltd.         510(k) NO: K161974(Special)
ATTN: Anne-Marie  Keenan          PHONE NO : 353 91 774316 
Parkmore Business Park West       SE DECISION MADE: 01-NOV-16
Galway  IE H91 NHT7               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AirFit N20
ResMed Ltd                        510(k) NO: K161978(Traditional)
ATTN: Kim Kuan Lee                PHONE NO : 61 2 88841000 
1 Elizabeth Macarthur Drive       SE DECISION MADE: 17-NOV-16
Bella Vista  AU 2153              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Leva® Anterior Interbody System
Spine Wave, Inc.                  510(k) NO: K161993(Traditional)
ATTN: Sanja  Jahr                 PHONE NO : 203 9449494 
3 Enterprise Drive, Suite 210     SE DECISION MADE: 22-NOV-16
Shelton CT  06484                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aixplorer
SUPERSONIC IMAGINE                510(k) NO: K161999(Traditional)
ATTN: LAURENCE  HERMITTE          PHONE NO : 33 442 992424 
Les Jardins de La Duranne-bat E & SE DECISION MADE: 16-NOV-16
AIX-EN-PROVENCE  FR 13857         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay
ZDi, Solutions, LLC               510(k) NO: K162002(Traditional)
ATTN: Zachary A. Dutton           PHONE NO : 865 8097283 
800 S Gay St, STE 714             SE DECISION MADE: 01-NOV-16
Knoxville TN  37909               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AltiVate Anatomic Shoulder System
ENCORE MEDICAL, L.P               510(k) NO: K162024(Traditional)
ATTN: DESIREE  WELLS              PHONE NO : 512 8346302 
9800 METRIC BLVD.                 SE DECISION MADE: 21-NOV-16
AUSTIN TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NobelProcera HT ML FCZ Bridge
Nobel Biocare AB                  510(k) NO: K162043(Traditional)
ATTN: Charlemagne  Chua           PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 22-NOV-16
Goteborg  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZELTIQ CoolSculpting System
ZELTIQ Aesthetics, Inc            510(k) NO: K162050(Traditional)
ATTN: Shruti  Jayakumar           PHONE NO : 925 4742516 
4698 Willow Road                  SE DECISION MADE: 21-NOV-16
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AVAmax Vertebral Balloon, AVAflex Vertebral Balloon
STRYKER CORPORATION               510(k) NO: K162062(Traditional)
ATTN: BECKY  DITTY                PHONE NO : 269 3893434 
4100 E MILHAM AVE                 SE DECISION MADE: 01-NOV-16
Kalamazoo MI  49001               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVOS Small Fragment Plating System
SMITH & NEPHEW, INC.              510(k) NO: K162078(Traditional)
ATTN: SAMANTHA  STAUBACH          PHONE NO : 901 3996132 
1450 BROOKS ROAD                  SE DECISION MADE: 18-NOV-16
MEMPHIS TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: i-CAT FLX V series / KaVo 3D eXam+ V series
IMAGING SCIENCES INTERNATIONAL    510(k) NO: K162085(Traditional)
ATTN: Ruth  Pui                   PHONE NO : 267 9541479 
1910 NORTH PENN RD.               SE DECISION MADE: 10-NOV-16
HATFIELD PA  19454                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Evolv Model BP7000 Upper Arm Blood Pressure Monitor
OMRON HEALTHCARE, INC.            510(k) NO: K162092(Traditional)
ATTN: RENEE  THORNBOROUGH         PHONE NO : 847 2475626 
1925 WEST FIELD COURT             SE DECISION MADE: 22-NOV-16
LAKE FOREST IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)
YTY INDUSTRY (MANJUNG) SDN. BHD., 510(k) NO: K162095(Traditional)
ATTN: Punitha  Samy               PHONE NO : 60 5 6792288 
Lot 1422-1424, Batu 10 Lekir      SE DECISION MADE: 02-NOV-16
Sitiawan  MY 32020                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InTRAkit
Medtronic Vascular                510(k) NO: K162097(Traditional)
ATTN: Nisarg  Shah                PHONE NO : 978 7396632 
37A Cherry Hill Drive             SE DECISION MADE: 17-NOV-16
Danvers MA  01923                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Avantofit, MAGNETOM Skyrafit
SIEMENS MEDICAL SOLUTIONS, INC.   510(k) NO: K162102(Traditional)
ATTN: JOHN  URTZ                  PHONE NO : 610 4486002 
40 LIBERTY BOULEVARD MAIL CODE 65-SE DECISION MADE: 22-NOV-16
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)
CHOICE SPINE, LP                  510(k) NO: K162103(Traditional)
ATTN: KIM  FINCH                  PHONE NO : 865 2463333 
400 Erin Drive                    SE DECISION MADE: 23-NOV-16
KNOXVILLE TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves (Blue)
NAM VIET GLOVE JOINT STOCK COMPANY510(k) NO: K162113(Traditional)
ATTN: OOI LOON SENG               PHONE NO : 84 083 5147788 
HAMLET 7, PHUOC BINH COMMUNE LONG SE DECISION MADE: 07-NOV-16
HO CHI MINH  VN 815300            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System
L&K BIOMED CO.,LTD.               510(k) NO: K162136(Traditional)
ATTN: Yerim  An                   PHONE NO : 82 2 67171985 
#201, 202 16-25, DONGBAEKJUNGANG-RSE DECISION MADE: 03-NOV-16
GIHEUNG-GU, YONGIN-SI  KR 446-916 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Allura Xper R9
PHILIPS MEDICAL SYSTEMS NETHRLANDS510(k) NO: K162148(Abbreviated)
ATTN: Jeanette  Becker            PHONE NO : 31 611 621238 
VEENPLUIS 4-6                     SE DECISION MADE: 23-NOV-16
BEST  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xario 200 Diagnostic Ultrasound System V5.0
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K162155(Traditional)
ATTN: PAUL  BIGGINS               PHONE NO : 714 6697808 
1385 SHIMOISHIGAMI                SE DECISION MADE: 01-NOV-16
OTAWARA-SHI  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Preference Elite Pedicle Screw System
AMEDICA CORPORATION               510(k) NO: K162160(Traditional)
ATTN: Shanna  Ryan                PHONE NO : 855 8393500 
1885 W 2100 S                     SE DECISION MADE: 18-NOV-16
Salt Lake City UT  84119          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Barrier Supreme Sterilization Wrapper
Standard Textile Co., Inc.        510(k) NO: K162162(Traditional)
ATTN: Bradley J. Bushman          PHONE NO : 513 7619255 2455
One Knollcrest Drive              SE DECISION MADE: 04-NOV-16
Cincinnati OH  45237              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UltraShape System
SYNERON MEDICAL LTD               510(k) NO: K162163(Traditional)
ATTN: Ruthie  Amir                PHONE NO : 972 732 442200 
TAVOR BUILDING, INDUSTRIAL ZONE, PSE DECISION MADE: 17-NOV-16
Yokneam Illit  IL 20692           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less
Viet Glove Corporation            510(k) NO: K162175(Traditional)
ATTN: PHAM NGOC THANH             PHONE NO : 84 0650 591220 
Cau Sat Hamlet, Lai Hung Commune BSE DECISION MADE: 21-NOV-16
Bau Bang Province  VN             510(k) STATEMENT
                                                    

DEVICE: Vantage Galan 3T, MRT-3020, V4.0
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K162183(Traditional)
ATTN: PAUL  BIGGINS               PHONE NO : 714 6697808 
1385 SHIMOISHIGAMI                SE DECISION MADE: 25-NOV-16
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NAVILAS Laser System
OD-OS GMBH                        510(k) NO: K162191(Traditional)
ATTN: WINFRIED  TEIWES            PHONE NO : 49 3328 31282100 
14513 WARTHESTR. 21               SE DECISION MADE: 22-NOV-16
TELTOW  DE 14513                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GFS Ultimate
PARCUS MEDICAL, LLC               510(k) NO: K162198(Special)
ATTN: PAUL  VAGTS                 PHONE NO : 941 7557965 
6423 PARKLAND DR                  SE DECISION MADE: 18-NOV-16
SARASOTA FL  34243                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: touchTymp
MAICO DIAGNOSTICS GMBH            510(k) NO: K162210(Special)
ATTN: UWE  LEDWORUSKI             PHONE NO : 49 307 0714661 
SICKINGENSTR. 70-71               SE DECISION MADE: 16-NOV-16
BERLIN  DE 10553                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AccuFit Lateral Plate System
PRECISION SPINE, INC.             510(k) NO: K162211(Traditional)
ATTN: Michael C. Dawson           PHONE NO : 973 4557150 
5 SYLVAN WAY SUITE 220            SE DECISION MADE: 28-NOV-16
Parsippany NJ  07930              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Protek Solo 24 Fr Venous Cannula Set
CARDIAC ASSIST, INC.              510(k) NO: K162214(Traditional)
ATTN: GREG  JOHNSON               PHONE NO : 412 9637770 
240 ALPHA DR.                     SE DECISION MADE: 30-NOV-16
PITTSBURGH PA  15238              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102
NUANCE MEDICAL, LLC               510(k) NO: K162218(Traditional)
ATTN: MARC  LIEBERMAN             PHONE NO : 760 5854849 
5931 Sea Lion Place, Suite 113    SE DECISION MADE: 22-NOV-16
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage
DIO MEDICAL CO., LTD              510(k) NO: K162220(Traditional)
ATTN: SUNG  HEE-LEE               PHONE NO : 82 31 7763690 
101-105 MEGACENTER, SK TECHNOPARK,SE DECISION MADE: 21-NOV-16
SAGIMAKGOL-RO JUNGWON-GU SEONGNAM-510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System
WellDoc, Inc                      510(k) NO: K162225(Traditional)
ATTN: Michele  Livingston         PHONE NO : 443 6923100 
10221 Wincopin Circle Suite 150   SE DECISION MADE: 22-NOV-16
Columbia MD  21044                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fully Automatic Electronic Blood Pressure Monitor
ADON HEALTH CO., LTD.             510(k) NO: K162230(Abbreviated)
ATTN: Liu  Yi                     PHONE NO : 86 22 60526161 9060
NO.3 JIN PING ST, YA AN RD, NANKAISE DECISION MADE: 18-NOV-16
Tianjin  CN 300190                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert
CYDEN LIMITED                     510(k) NO: K162231(Special)
ATTN: MIKE  KIERNAN               PHONE NO : 44 1792 485519 
TECHNIUM 2, KINGS ROAD            SE DECISION MADE: 16-NOV-16
SWANSEA  GB SA1 8PJ               510(k) STATEMENT
                                                    

DEVICE: MOSS 100 Pedicle Screw System
Biedermann Motech GmbH & Co. KG   510(k) NO: K162232(Traditional)
ATTN: Gerd  Federle               PHONE NO : 49 7720 8510545 
Bertha-von-Suttner-Straße 23      SE DECISION MADE: 17-NOV-16
Villingen-Schwenningen  DE 78054  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProMedTek Model C1400 Shortwave Diathermy Device
PROMEDTEK INC.                    510(k) NO: K162240(Traditional)
ATTN: Dan  Puchek                 PHONE NO : 480 3852488 
4110 N. SCOTTSDALE RD., SUITE 270 SE DECISION MADE: 17-NOV-16
Scottsdale AZ  85251              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FasTouch Fixation System
VIA SURGICAL LTD.                 510(k) NO: K162252(Special)
ATTN: OFEK  LEVIN                 PHONE NO : 972 52 6395765 
MITZPE KINERET STREET 22/1        SE DECISION MADE: 14-NOV-16
MOSHAV AMIRIM  IL 20115           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: P1145 Dental Restorative
Kerr Corporation                  510(k) NO: K162257(Traditional)
ATTN: Mohammad Saad Ansari        PHONE NO : 909 9625644 
1717 W. Collins Ave               SE DECISION MADE: 07-NOV-16
Orange CA  92867                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tritanium® PL Cage
STRYKER                           510(k) NO: K162262(Traditional)
ATTN: Deirdre  Jayko              PHONE NO : 201 7498339 
2 Pearl Court                     SE DECISION MADE: 09-NOV-16
Allendale NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CushionCast Moldable Cushions
IZI Medical Products LLC          510(k) NO: K162265(Traditional)
ATTN: Qiang  Cao                  PHONE NO : 443 8262997 
5 Easter Court Suite J            SE DECISION MADE: 15-NOV-16
Owings Mills MD  21117            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Senographe Pristina
GE HEALTHCARE                     510(k) NO: K162268(Traditional)
ATTN: Gregory  Pessato            PHONE NO : 33 1 30709316 
283 RUE DE LA MINIERE             SE DECISION MADE: 03-NOV-16
BUC  FR 78530                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Materialise TKA Guide System
MATERIALISE NV                    510(k) NO: K162273(Traditional)
ATTN: OLIVER  CLEMENS             PHONE NO : 32 163 96280 
TECHNOLOGIELAAN 15                SE DECISION MADE: 07-NOV-16
LEUVEN  BE 3001                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Diagnostic Mobile X-ray System
SAMSUNG ELECTRONICS CO., LTD.     510(k) NO: K162278(Traditional)
ATTN: CHULSIN  KIM                PHONE NO : 82 312 007661 
129, SAMSUNG-RO, YEONGTONG-GU     SE DECISION MADE: 15-NOV-16
SUWON-SI  KR 16677                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Puritan Fecal Opti-Swab Collection and Transport System
PURITAN MEDICAL PRODUCTS LLC      510(k) NO: K162284(Traditional)
ATTN: MEHDI  KARAMCHI             PHONE NO : 207 8763311 3284
31 SCHOOL STREET P.O. BOX 149     SE DECISION MADE: 04-NOV-16
GUILFORD ME  04443                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reform® POCT System
PRECISION SPINE, INC.             510(k) NO: K162300(Traditional)
ATTN: MICHAEL C. DAWSON           PHONE NO : 601 4204244 
2050 EXECUTIVE DRIVE              SE DECISION MADE: 22-NOV-16
PEARL MS  39208                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XBraid TT Suture Tape
Stryker                           510(k) NO: K162310(Traditional)
ATTN: Taylor  White               PHONE NO : 303 3367285 
5670 Greenwood Plaza Blvd., Suite SE DECISION MADE: 10-NOV-16
Greenwood Village CO  80111       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pirouette 014
ArraVasc Ltd                      510(k) NO: K162316(Special)
ATTN: Aoife  Donoghue             PHONE NO : 353 91 758939 54
2 Ballybrit Business Park         SE DECISION MADE: 22-NOV-16
Galway  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model
ACCESS SCIENTIFIC, LLC            510(k) NO: K162322(Traditional)
ATTN: WALTER  CORDIGLIA           PHONE NO : 1 858 4800216 
3910 Sorrento Valley Blvd Ste 200 SE DECISION MADE: 17-NOV-16
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018"
Boston Scientific Corporation     510(k) NO: K162350(Special)
ATTN: Ka Zoua Xiong               PHONE NO : 763 4942970 
One Scimed Place                  SE DECISION MADE: 04-NOV-16
Maple Grove MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Raycast MammoRx Carbon Fibre Breast Board
Orfit Industries NV               510(k) NO: K162355(Traditional)
ATTN: Eddy  Marivoet              PHONE NO : 32 0 33262026 
9A, VOSVELD                       SE DECISION MADE: 22-NOV-16
WIJNEGEM  BE 2110                 510(k) STATEMENT
                                                    

DEVICE: T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System
SYNTHES USA PRODUCTS LLC          510(k) NO: K162358(Traditional)
ATTN: Eugene  Bang                PHONE NO : 508 9773966 
325 Paramount Drive               SE DECISION MADE: 01-NOV-16
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: V30 system, V-Form Handpiece BC Medium applicator
Viora Ltd.                        510(k) NO: K162363(Traditional)
ATTN: Stella Raizelman Perry      PHONE NO : 972 9 9551344 
6 Hagavish Street                 SE DECISION MADE: 18-NOV-16
Netanya  IL 4250706               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CD HORIZON® Spinal System
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K162379(Traditional)
ATTN: Nathaniel  Hendricks        PHONE NO : 901 3441208 
1800 Pyramid Place                SE DECISION MADE: 16-NOV-16
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SILK Surgical Suture
TELEFLEX MEDICAL, INC             510(k) NO: K162396(Traditional)
ATTN: NATALIE  HICHAK             PHONE NO : 919 4338049 
3015 CARRINGTON MILL BLVD         SE DECISION MADE: 23-NOV-16
MORRISVILLE NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HyperBand
GE Medical Systems, LLC           510(k) NO: K162403(Traditional)
ATTN: Jason  Ma                   PHONE NO : 262 3522892 
3200 North Grandview Blvd         SE DECISION MADE: 18-NOV-16
Waukesha WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System
BECKMAN COULTER, INC.             510(k) NO: K162414(Special)
ATTN: NANCY  NADLER               PHONE NO : 305 3804191 
11800 SW 147TH AVE.               SE DECISION MADE: 29-NOV-16
MIAMI FL  33196                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Luna 3D Interbody Fusion System
Benvenue Medical, Inc.            510(k) NO: K162431(Traditional)
ATTN: Jeff  Emery                 PHONE NO : 408 4549300 
5403 Betsy Ross Drive             SE DECISION MADE: 17-NOV-16
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CardioInsight Cardiac Mapping System
CARDIOINSIGHT TECHNOLODIES, INC   510(k) NO: K162440(Special)
ATTN: LAURIE  LEWANDOWSKI         PHONE NO : 612 7704038 
11000 CEDAR AVE SUITE 210         SE DECISION MADE: 04-NOV-16
CLEVELAND OH  44106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xpert MRSA NxG
CEPHEID                           510(k) NO: K162444(Traditional)
ATTN: SCOTT A. CAMPBELL           PHONE NO : 847 2283299 
904 CARIBBEAN DRIVE               SE DECISION MADE: 23-NOV-16
SUNNYVALE CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ESPADA Acne-Clearing Blue Light Pen
FOREO INC.                        510(k) NO: K162450(Traditional)
ATTN: Davor  Soldo                PHONE NO : 855 7736736 
1525 Pama Lane, Suite 200         SE DECISION MADE: 30-NOV-16
Las Vegas NV  89119               510(k) STATEMENT
                                                    

DEVICE: Solana HSV 1+2/VZV Assay
QUIDEL CORPORATION                510(k) NO: K162451(Traditional)
ATTN: Ronald H. Lollar            PHONE NO : 740 5893373 
2005 EAST STATE STREET, SUITE 100 SE DECISION MADE: 28-NOV-16
ATHENS OH  45701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)
Pan Medical Ltd.                  510(k) NO: K162453(Special)
ATTN: Jennie  Budding             PHONE NO : 44 1452 621621 
Barnett Way, Barnwood             SE DECISION MADE: 01-NOV-16
Gloucester  GB GL4 3RT            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
Rocket Medical Plc                510(k) NO: K162457(Traditional)
ATTN: Tracy  Charlton             PHONE NO : 0044 191 4194488 222
2-4 Sedling Road, Wear Industrial SE DECISION MADE: 14-NOV-16
Washington  GB NE38 9BZ           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMICUS Separator System, AMICUS Separator System; Refurbished
FRESENIUS KABI USA LLC            510(k) NO: K162462(Traditional)
ATTN: KIM  FORCH                  PHONE NO : 847 5507962 
THREE CORPORATE DRIVE             SE DECISION MADE: 23-NOV-16
LAKE ZURICH IL  60047             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LuminScan (TM) Imaging System
MICRO-TECH (NANJING) CO.,LTD.     510(k) NO: K162466(Traditional)
ATTN: Becky  Li                   PHONE NO : 86 25 58646378 
NO. 10 GAOKE THIRD ROAD           SE DECISION MADE: 29-NOV-16
NANJING  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAD/CAMouflage Milling Block
PRISMATIK DENTALCRAFT, INC.       510(k) NO: K162537(Special)
ATTN: ALIVA  DAS                  PHONE NO : 949 2251249 
2212 DUPONT DRIVE, SUITE P        SE DECISION MADE: 16-NOV-16
IRVINE CA  92612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K162538(Special)
ATTN: SUSAN  FERRIN               PHONE NO : 508 6604487 
333 CONEY STREET                  SE DECISION MADE: 17-NOV-16
E. WALPOLE MA  02032              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solitaire 2 Revascularization Device
MICRO THERAPEUTICS, INC. D/B/A EV3510(k) NO: K162539(Traditional)
ATTN: JENNIFER  CORREA            PHONE NO : 949 2979563 
9775 TOLEDO WAY                   SE DECISION MADE: 10-NOV-16
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo Application Software
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K162541(Traditional)
ATTN: PATRICIA D. JONES           PHONE NO : 610 4486474 
40 LIBERTY BOULEVARD 65-1A        SE DECISION MADE: 16-NOV-16
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source
SOURCE PRODUCTION AND EQUIPMENT CO510(k) NO: K162573(Traditional)
ATTN: KELLEY  RICHARDT            PHONE NO : 504 4649471 
113 TEAL STREET                   SE DECISION MADE: 04-NOV-16
SAINT ROSE LA  70087              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORTEZZA Spinal Stabilization System
OSSO SURGICAL                     510(k) NO: K162576(Traditional)
ATTN: Basheer  Hassan             PHONE NO : 875 5131774 
2150 W 43RD ST                    SE DECISION MADE: 10-NOV-16
Chicago IL  60609                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dosimetry Check Version 5 Release 1
MATH RESOLUTIONS, LLC             510(k) NO: K162577(Traditional)
ATTN: WENDEL DEAN RENNER          PHONE NO : 410 9979578 
5975 GALES LANE                   SE DECISION MADE: 18-NOV-16
COLUMBIA MD  21045                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALOKA LISENDO 880
HITACHI, LTD.                     510(k) NO: K162583(Traditional)
ATTN: ANGELA VAN ARSDALE          PHONE NO : 203 2695088 346
10 FAIRFIELD BLVD                 SE DECISION MADE: 17-NOV-16
WALLINGFORD CT  06492-5903        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SuniIQ Digital Radiography System
Suni Medical Imaging, Inc         510(k) NO: K162585(Third Party - Traditional)
ATTN: Al  Bettencourt             PHONE NO : 408 3370573 
6840 Via Del Oro Suite 160        SE DECISION MADE: 04-NOV-16
San Jose CA  95119                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Trex_HD
Natus Medical Incorporated DBA Exc510(k) NO: K162595(Traditional)
ATTN: Sanjay  Mehta               PHONE NO : 905 8295300 
2568 Bristol Circle               SE DECISION MADE: 04-NOV-16
Oakville  CA L6H 5S1              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: I View and Imagen Sensor
TRIDENT S.R.L.                    510(k) NO: K162619(Traditional)
ATTN: GIORGIO  RIZZO              PHONE NO : 39 02 87072380 
VIA VERDI 20                      SE DECISION MADE: 04-NOV-16
ASSAGO  IT 20090                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ESU-1 Electrosurgical Generator
TVA Medical, Inc.                 510(k) NO: K162656(Traditional)
ATTN: Katherine  Kumar            PHONE NO : 612 7165578 
7000 Bee Caves Rd., Suite 250     SE DECISION MADE: 10-NOV-16
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ViewPoint 6
GE MEDICAL SYSTEMS ULTRASOUND AND 510(k) NO: K162743(Traditional)
ATTN: TRACEY  ORTIZ               PHONE NO : 262 6766120 
9900 W INNOVATION DRIVE           SE DECISION MADE: 22-NOV-16
WAUWATOSA WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pinpoint GT Introducer Needle
C.R. BARD, INC.                   510(k) NO: K162769(Special)
ATTN: Jamie  Howell               PHONE NO : 801 5225465 
605 NORTH 5600 WEST               SE DECISION MADE: 04-NOV-16
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Magma Spark
Formatk Systems Ltd.              510(k) NO: K162781(Special)
ATTN: Ahava  Stein                PHONE NO : 972 4 8571848 
3 Hayozma St.                     SE DECISION MADE: 09-NOV-16
Tirat Hacarmel  IL 3903203        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CastleLoc Spinal Fixation System
L&K BIOMED CO., LTD.              510(k) NO: K162801(Special)
ATTN: Yerim  An                   PHONE NO : 82 267 171985 
#201, 202 16-25, DONGBAEKJUNGANG-RSE DECISION MADE: 03-NOV-16
Giheung-gu, Yongin-si  KR 17015   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Small (4") Roller Pump for the Terumo Advanced Perfusion System 1, Large (6") Roller Pump for the Terumo Advanced Perfusion System 1
Terumo Cardiovascular Systems Corp510(k) NO: K162843(Special)
ATTN: Bryan  Hann                 PHONE NO : 734 7415816 
6200 Jackson Road                 SE DECISION MADE: 17-NOV-16
Ann Arbor MI  48103               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Raycast High Precision Lung Board Solution
Orfit Industries NV               510(k) NO: K162862(Third Party - Traditional)
ATTN: Raymond  Kelly              PHONE NO : 203 4007566 
9A VOSVELD                        SE DECISION MADE: 09-NOV-16
WIJNEGEM  BE 2110                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: dS Small Extremity 16CH 1.5T Coil
INVIVO THERAPEUTICS CORPORATION   510(k) NO: K162863(Third Party - Traditional)
ATTN: Ken  Revennaugh             PHONE NO : 352 3848590 
3545 SW 47th Ave                  SE DECISION MADE: 07-NOV-16
Gainesville FL  32608             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Achieve Advance Mapping Catheter
MEDTRONIC INC.                    510(k) NO: K162892(Special)
ATTN: HEATHER  TAYLOR             PHONE NO : 763 5269066 
8200 CORAL SEA STREET NE MAIL STOPSE DECISION MADE: 15-NOV-16
MOUNDS VIEW MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AccuCath Intravascular Catheter
C.R.BARD, INC.                    510(k) NO: K162894(Special)
ATTN: JACOB  LEE                  PHONE NO : 801 5225823 
605 N 5600 W                      SE DECISION MADE: 15-NOV-16
SALT LAKE CITY UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VenaCure EVLT NeverTouch Procedure Kit
AngioDynamics, Inc.               510(k) NO: K162914(Special)
ATTN: Robin  Fuller               PHONE NO : 508 6587986 
26 Forest Street                  SE DECISION MADE: 16-NOV-16
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ligasure Blunt Tip, Sealer/Divider, Nano-coated
COVIDIEN                          510(k) NO: K162941(Special)
ATTN: CELSO  DURAN                PHONE NO : 303 5306445 
5920 LONGBOW DRIVE                SE DECISION MADE: 14-NOV-16
BOULDER CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Irix-C Cervical Integrated Fusion System
X-SPINE SYSTEMS, INC.             510(k) NO: K162944(Traditional)
ATTN: KRISS  ANDERSSON            PHONE NO : 937 8478400 2137
452 ALEXANDERSVILLE RD.           SE DECISION MADE: 07-NOV-16
MIAMISBURG OH  45342              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TxRx Knee 15 Flare MR Coil 1.5T
Quality Electrodynamics, LLC      510(k) NO: K162966(Traditional)
ATTN: Kathleen  Aras              PHONE NO : 440 4842964 
6655 Beta Drive Suite 100         SE DECISION MADE: 30-NOV-16
Mayfield Village OH  44143        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator
Inari Medical                     510(k) NO: K162970(Special)
ATTN: Eben  Gordon                PHONE NO : 949 6008433 
9272 Jeronimo Rd., Suite 124      SE DECISION MADE: 22-NOV-16
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Multix Fusion Max
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K162971(Special)
ATTN: DENISE  ADAMS               PHONE NO : 610 4486139 
40 LIBERTY BOULEVARD, MAIL CODE 65SE DECISION MADE: 22-NOV-16
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optima XR240amx
GE Medical Systems, LLC           510(k) NO: K162990(Special)
ATTN: Chris  Paulik               PHONE NO : 262 5482010 
3000 N. Grandview Blvd.           SE DECISION MADE: 15-NOV-16
Waukesha WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Capillus302, Capillus312, Capillus352
CAPILLUS, LLC                     510(k) NO: K162994(Special)
ATTN: PATRICIA  SCHNOOR           PHONE NO : 786 8881874 
1715 NW 82nd AVE                  SE DECISION MADE: 18-NOV-16
MIAMI FL  33126                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biomet Microfixation SternaLock 360 Sternal Closure System
BIOMET MICROFIXATION              510(k) NO: K163007(Special)
ATTN: LAUREN  JASPER              PHONE NO : 904 7419259 
1520 TRADEPORT DRIVE              SE DECISION MADE: 23-NOV-16
JACKSONVILLE FL  32218            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xperius Ultrasound System
PHILIPS HEALTHCARE                510(k) NO: K163020(Third Party - Traditional)
ATTN: SCOTT  ZHANG                PHONE NO : 425 4877000 
22100 BOTHELL EVERETT HIGHWAY     SE DECISION MADE: 16-NOV-16
BOTHELL WA  98021-8431            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Zeramex P6 Dental Implant System
DENTALPOINT AG                    510(k) NO: K163043(Special)
ATTN: Viktor  Lienhard            PHONE NO : 41 44 3883636 
Hohlstrasse 614                   SE DECISION MADE: 30-NOV-16
Zurich  CH 8048                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TxRx Knee 15 Flare MR Coil 3.0T
QUALITY ELECTRODYNAMICS, LLC      510(k) NO: K163066(Traditional)
ATTN: Kathleen  Aras              PHONE NO : 440 4842964 
6655 BETA DRIVE SUITE 100         SE DECISION MADE: 29-NOV-16
Mayfield Village OH  44143        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOGIQ E9, LOGIQ E9 XDClear 2.0
GE Medical Systems Ultrasound and 510(k) NO: K163077(Special)
ATTN: Bryan  Behn                 PHONE NO : 414 7214214 
9900 Innovation Dr.               SE DECISION MADE: 17-NOV-16
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TubeClear Control Box and Clearing Stem
Actuated Medical, Inc.            510(k) NO: K163092(Third Party - Traditional)
ATTN: Thomas L. Cronin            PHONE NO : 814 3550003 118
310 Rolling Ridge Drive           SE DECISION MADE: 30-NOV-16
Bellefonte PA  16801              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm
COVIDIEN                          510(k) NO: K163102(Special)
ATTN: KATIE  BROWN                PHONE NO : 203 4928350 
60 MIDDLETON AVE.                 SE DECISION MADE: 30-NOV-16
NORTH HAVEN CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clarius Ultrasound System
Clarius Mobile Health Corp.       510(k) NO: K163138(Third Party - Abbreviated)
ATTN: Abhijit  Ahir               PHONE NO : 1 788 8009975 
350 - 3605 Gilmore Way            SE DECISION MADE: 30-NOV-16
Burnaby  CA V5G 4X5               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PleuraFlow System with FlowGlide
CLEARFLOW, INC.                   510(k) NO: K163139(Special)
ATTN: DOV  GAL                    PHONE NO : 714 9165014 
1630 S. SUNKIST ST. SUITE E       SE DECISION MADE: 30-NOV-16
ANAHEIM CA  92806                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OptiLux LED Illuminator
ISOLUX LLC                        510(k) NO: K163185(Third Party - Traditional)
ATTN: NIKOLAOS  ANDREOULAKIS      PHONE NO : 239 5147475 
1045 COLLIER CENTER WAY SUITE #6  SE DECISION MADE: 21-NOV-16
NAPLES FL  34110                  510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: Filtek One Bulk Fill Restorative
3M Company                        510(k) NO: K163207(Third Party - Traditional)
ATTN: Scott  Erickson             PHONE NO : 651 7369883 
2510 Conway Ave.                  SE DECISION MADE: 28-NOV-16
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

The post FDA releases November 2016 510(k) clearances appeared first on MassDevice.

Wound care and regenerative medicine company Acelity yesterday spiked an initial public offering that could have fetched as much as $1 billion.

Acelity, formerly Kinetic Concepts Inc., was acquired for $6.1 billion by Apax Partners and a pair of Canadian pension funds in a leveraged buyout in November 2011. The company, which makes wound care products, later folded KCI sister company LifeCell and acquisition Systagenix into the Acelity brand.

Last August the company registered for the IPO, confirming rumors that 1st surfaced in June 2015 that its private equity owners are looking look to pay down debt. Yesterday Acelity, which had planned to list on the New York Stock Exchange, asked the SEC to withdraw its registration.

“In light of current public market conditions, the registrant has determined not to proceed with the proposed initial public offering,” the company said in a regulatory filing. “Because the proposed offering will not occur, the registrant believes that the withdrawal of the registration statement is consistent with the public interest and the protection of investors.”

Proceeds from the flotation were slated to redeem some of the $609.6 million it has in 12.5% senior notes, which come due in 2019. Acelity had more than $1.73 billion in 10.5% 2nd-lien senior secured notes, due 2018, and total debt of $4.84 billion as of June 30, 2015.

In October 2013, then-KCI paid $485 million to acquire Systagenix, the wound care business spun out of Johnson & Johnson (NYSE:JNJ) in 2008. The company united Systagenix, LifeCell and KCI under the Acelity brand in September 2013.

The post Acelity spikes $1B IPO appeared first on MassDevice.

The U.S. Food and Drug Administration today announced important steps to better support consumer access to hearing aids. The agency issued a guidance document explaining that it does not intend to enforce the requirement that individuals 18 and up receive a medical evaluation or sign a waiver prior to purchasing most hearing aids. This guidance is effective immediately. Today, the FDA is also announcing its commitment to consider creating a category of over-the-counter (OTC) hearing aids that could deliver new, innovative and lower-cost products to millions of consumers.

“Today’s actions are an example of the FDA considering flexible approaches to regulation that encourage innovation in areas of rapid scientific progress,” said FDA Commissioner Robert Califf, M.D. “The guidance will support consumer access to most hearing aids while the FDA takes the steps necessary to propose to modify our regulations to create a category of OTC hearing aids that could help many Americans improve their quality of life through better hearing.”

The FDA has cited that hearing loss affects some 30 million people in the United States and can have a significant impact on communication, social participation and overall health and quality of life. Despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid seek intervention.

In October 2015, the President’s Council of Advisors on Science and Technology (PCAST) issued recommendations intended to facilitate hearing aid device innovation, and improve affordability and patient access. Additionally, the FDA and other federal agencies and a consumer advocacy group sponsored a studypublished by the National Academies of Sciences, Engineering and Medicine (NAS) in June 2016.

Both PCAST and NAS cited FDA regulations regarding conditions for sale as a potential barrier to availability and accessibility of hearing aids, and concluded that the regulation was providing little to no meaningful benefit to patients. PCAST noted that, at present, hearing aids often cost more than $2,000 a piece, and such barriers to distribution channels may limit new entrants who could achieve technological breakthroughs that could offer a greater variety of lower-cost hearing aid options to those suffering from hearing loss. The regulation requires that all prospective hearing aid users have a medical evaluation by a licensed physician to determine the cause of hearing loss and whether medical or surgical treatments would be more appropriate. Individuals 18 and up may waive the requirement for a medical evaluation by signing a waiver statement.

For the guidance document issued today, the FDA considered recommendations from the PCAST and NAS reports and public comments received on a draft guidance issued in 2013, as well as comments received at an April 2016 FDA workshop.

Under the new guidance, the FDA will continue to enforce the medical evaluation requirement for prospective hearing aid users under 18. Under the FDA’s hearing aid regulations, hearing aid labeling must include information about medical conditions that should be evaluated by a licensed physician. In addition, the FDA requires that information and instructions about hearing aids be provided to consumers before any purchase from a licensed hearing aid dispenser.

The guidance is “Immediately in Effect,” which means it is implemented without prior public comment because it presents a less burdensome policy that is consistent with public health. The public can still comment on the guidance, and the FDA will consider all comments received and revise the guidance document as appropriate.

The FDA intends to consider and address PCAST and NAS recommendations regarding a regulatory framework for over-the-counter hearing aids without the requirement for consultation with a credentialed dispenser. The agency is committed to seeking additional public input before proposing such an approach.

The post FDA takes steps to improve hearing aid accessibility appeared first on MassDevice.

Researchers from the Beijing University of Chemical Technology have developed a method to introduce a bubble-shaped microstructure into the base of drug-loaded dissolving microneedles for use as a transdermal drug delivery system. The team’s work was published today in Scientific Reports. 

Drug-loaded dissolving microneedles are made with water soluble polymers and are designed to overcome the barrier properties of the skin for transdermal delivery. The microneedle can painlessly pierce the skin’s protective stratum corneum, creating microchannels for the therapeutic to travel through. Once the drug passes through the barrier of skin, it can diffuse into the subcutaneous tissues.

Get the full story at our sister site, Drug Delivery Business News.

The post Researchers use drug-loaded microneedles for transdermal delivery appeared first on MassDevice.

St. Jude Medical (NYSE:STJ) said today that it won CE Mark approval in the European Union for full-body MRI scans of patients implanted with its Proclaim Elite spinal cord stimulation device.

Little Canada, Minn.-based St. Jude said the MR-conditional label adds to the head and extremity CE Mark Proclaim Elite landed last year. The FDA cleared the system for full-body MRIs last month; St. Jude won FDA approval for the Proclaim Elite in November 2015, claiming it as the sole U.S.-approved upgradable and recharge-free SCS system.

The device uses St. Jude’s “BurstDr” technology, which is designed to reduce the sensation of tingling along the spinal cord called paresthesia that’s associated with tonic stimulation. The Proclaim Elite device can also be fine-tuned via Bluetooth by doctors using Apple’s (NSDQ:AAPL) mobile devices, which can also be used as the patient’s controller, St. Jude said.

“Historically, the need for future MRI scans could act as a barrier to patients who may benefit from SCS therapy,” medical affairs VP Dr. Allen Burton said in prepared remarks. “Our new labeling for the Proclaim Elite SCS system ensures that patients can receive the treatment they need, while having peace of mind knowing their SCS system can be safely scanned with the diagnostic imaging they require.”

“Providing patients with a multitude of therapy options in one device has positively impacted the way we treat chronic pain patients today,” added Dr. Dirk Rasche of Lübeck, Germany’s University Hospital of Schleswig-Holstein. “Patients now do not only have access to both traditional SCS and BurstDR stimulation, they can also safely undergo MRI scans, a significant improvement for future neuromodulation therapy and diagnostic options.”

The post St. Jude Medical wins CE Mark for full-body MRI scans with Proclaim Elite SCS device appeared first on MassDevice.