510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD September 2016 TOTAL 510(k)s THIS PERIOD 257 TOTAL WITH SUMMARIES 250 TOTAL WITH STATEMENTS 7 DEVICE: BBX1, BBX2, BBX1MO, BBX1MC GLOBALDENTAL, INC. 510(k) NO: K142846(Traditional) ATTN: EBLESS V BAEZ ALERS PHONE NO : 787 8440345 SAN ANTONIO DRAMA ST. 2067 SE DECISION MADE: 08-SEP-16 PONCE PR 00728 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CPL Insulin Pen Needle CPL CO., LTD. 510(k) NO: K151090(Traditional) ATTN: CHOI KYOUNG SOO PHONE NO : 82 31 4837301 36, YONGTEURIM-GIL, DANWON-GU SE DECISION MADE: 21-SEP-16 ANSAN KP 425-430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VSP Cranial System 3D Systems, Inc. 510(k) NO: K151285(Traditional) ATTN: Kim Torluemke PHONE NO : 303 2735344 17301 West Colfax Avenue, Suite 30SE DECISION MADE: 23-SEP-16 Golden CO 80401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3Shape Abutment Designer Software 3Shape A/S 510(k) NO: K151455(Traditional) ATTN: Hanne Nielsen PHONE NO : 45 702 72620 Holemens Kanal 7 SE DECISION MADE: 06-SEP-16 Copenhagen DK 1060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD MAX CT/GC/TV, BD MAX INSTRUMENT BECTON, DICKINSON, AND COMPANY 510(k) NO: K151589(Traditional) ATTN: KATIE COYLE PHONE NO : 410 3164975 7 LOVETON CIR. MC:694 SE DECISION MADE: 06-SEP-16 SPARKS MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMC Health VitalCaregiving System AMC Health 510(k) NO: K151839(Traditional) ATTN: Jonathan Shankman PHONE NO : 212 5370827 39 Broadway, Suite 540 SE DECISION MADE: 09-SEP-16 New York NY 10006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KBL Sunlamp Products (= Device Bundling name) KBL AG 510(k) NO: K151962(Traditional) ATTN: NORBERT BECKER PHONE NO : 49 02689 9426525 RINGSTRASSE 24-26 SE DECISION MADE: 15-SEP-16 DERNBACH DE 56307 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Xprecia Stride Coagulation System, Xprecia System PT Controls SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K151964(Traditional) ATTN: NOOR MALKI PHONE NO : 781 2693401 2 EDGEWATER DRIVE SE DECISION MADE: 30-SEP-16 NORWOOD MA 02062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Luminesse Shaded Zirconia SZ TALLADIUM, INC. 510(k) NO: K152023(Traditional) ATTN: Edward Harms PHONE NO : 661 2950900 27360 WEST MUIRFIELD LANE SE DECISION MADE: 15-SEP-16 VALENCIA CA 91355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RENASYS GO SMITH & NEPHEW, INC. 510(k) NO: K152163(Traditional) ATTN: Laura Reynolds PHONE NO : 727 3297702 970 LAKE CARILLON DRIVE SUITE 110 SE DECISION MADE: 29-SEP-16 ST. PETERSBURG FL 33716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IBL 5000 Tanning Booth IBL ACQUISITIONS LLC 510(k) NO: K152405(Traditional) ATTN: MICHAEL GILLEY PHONE NO : 317 2171700 2653 TOBEY DRIVE SE DECISION MADE: 01-SEP-16 INDIANAPOLIS IN 46219 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRACOE smart Cuff Manager TRACOE MEDICAL GMBH 510(k) NO: K152865(Traditional) ATTN: STEPHAN KOHLER PHONE NO : 49 0 61369169 0 REICHELSHEIMER STR. 1/3 SE DECISION MADE: 27-SEP-16 NIEDER-OLM DE D-55268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sure-Fine Insulin Syringes SHINA MED CORPORATION 510(k) NO: K152879(Traditional) ATTN: SUNG-SOON PARK PHONE NO : 82 31 80572125 455-30, BOGAWONSAM-RO BOGAE-MYUN SE DECISION MADE: 09-SEP-16 ANSEONG-SI KR 456-871 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEMPEDY SEIRATHERM GMBH 510(k) NO: K152946(Traditional) ATTN: MATTHIAS ROTH PHONE NO : 49 898 09131420 BEETHOVEN STREET. 10 SE DECISION MADE: 15-SEP-16 91074 HERZOGENAURACH DE 13033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JET SET 4 DENTURE REPAIR RESIN LANG DENTAL MANUFACTURING COMPANY,510(k) NO: K152981(Traditional) ATTN: DAVID LANG PHONE NO : 800 2225264 175 MESSNER DRIVE SE DECISION MADE: 02-SEP-16 WHEELING IL 60090 510(k) STATEMENT DEVICE: HAMILTON-MR1 HAMILTON MEDICAL AG 510(k) NO: K153046(Traditional) ATTN: KATRIN VOGT PHONE NO : 41 58 6101479 VIA CRUSCH 8 SE DECISION MADE: 06-SEP-16 BONADUZ, GRISONS CH 7402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Initial LiSi Block GC AMERICA INC. 510(k) NO: K153130(Traditional) ATTN: MARK HEISS PHONE NO : 708 5970900 3737 W. 127TH STREET SE DECISION MADE: 13-SEP-16 ALSIP IL 60803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: eCareManager 4.0.1 VISICU, INC. 510(k) NO: K153156(Traditional) ATTN: Daniel R. Plonski PHONE NO : 410 2465357 217 E. REDWOOD ST., STE. 1900 SE DECISION MADE: 30-SEP-16 BALTIMORE MD 21202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Additive Orthopaedics Bone Wedge System Additive Orthopaedics, LLC 510(k) NO: K153207(Traditional) ATTN: GREGORY KOWALCZYK PHONE NO : 732 8826633 83 Amelia Circle SE DECISION MADE: 07-SEP-16 Little Silver NJ 07739 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: coflex-IF PARADIGM SPINE, LLC 510(k) NO: K153302(Traditional) ATTN: Marc Viscogliosi PHONE NO : 212 5839700 103 505 PARK AVENUE, 14TH FLOOR SE DECISION MADE: 08-SEP-16 NEW YORK NY 10022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Flexitouch System TACTILE SYSTEMS TECHNOLOGY INC (DB510(k) NO: K153311(Traditional) ATTN: Thomas A Dold PHONE NO : 612 3555100 1331 Tyler St NE, Ste 200 SE DECISION MADE: 14-SEP-16 MINNEAPOLIS MN 55413 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Luna CPAP and Auto CPAP System 3B MEDICAL, INC. 510(k) NO: K153387(Traditional) ATTN: ALEX LUCIO PHONE NO : 1 863 2266285 21301 HWY 27 SE DECISION MADE: 08-SEP-16 LAKE WALES FL 33859 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cathtong I PICC Catheter L&Z US, INC. 510(k) NO: K153469(Traditional) ATTN: JENELLA COUTTS PHONE NO : 718 6010889 1 6 HORIZON ROAD, #2301 SE DECISION MADE: 01-SEP-16 FORT LEE NJ 07024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: F&P Eson 2 Nasal Mask FISHER & PAYKEL HEALTHCARE LIMITED510(k) NO: K153505(Traditional) ATTN: SUE CHO PHONE NO : 64 957 40100 15 MAURICE PAYKEL PLACE EAST TAMAKSE DECISION MADE: 20-SEP-16 Auckland NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pelican Sling Retractor Beacon Surgical, Inc. 510(k) NO: K153542(Traditional) ATTN: Allan Alward PHONE NO : 914 4795108 145 Palisade Street SE DECISION MADE: 07-SEP-16 Dobbs Ferry NY 10522 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PINK CAD/CAM disc POLIDENT D.O.O., DENTAL PRODUCTS I510(k) NO: K153546(Traditional) ATTN: JANJA LIPUSCEK PHONE NO : 00386 53304859 VOLCJA DRAGA 42 SE DECISION MADE: 28-SEP-16 VOLCJA DRAGA SI 5293 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DONASORB SILVER WOUND DRESSING VIRCHOW BIOTECH PVT. LTD. 510(k) NO: K153565(Traditional) ATTN: BRUCE GIBBINS PHONE NO : 971 503781 7565 5903, SE MILWAUKIE AVENUE SE DECISION MADE: 22-SEP-16 PORTLAND OR 97202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Central Monitoring System GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K153580(Traditional) ATTN: Jin Liang PHONE NO : 86 756 3399967 NO. 2 INNOVATION FIRST ROAD TECHNSE DECISION MADE: 07-SEP-16 ZHUHAI CN 519085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Concert Medical Hands-Free Syringe (HFS) Concert Medical, LLC 510(k) NO: K153599(Traditional) ATTN: Timothy S Powers PHONE NO : 781 2617407 77 Accord Park Drive SE DECISION MADE: 01-SEP-16 Norwell MA 02061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RTS Flexible 1 MPJ Implant w/Grommets In2BonesUSA, LLC 510(k) NO: K153609(Traditional) ATTN: Joe Clift PHONE NO : 901 2607931 6060 Poplar Ave, Suite 380 SE DECISION MADE: 08-SEP-16 Mephis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Liberator Powered Wheelchair with Solar Companion SOLAR MOBILITYLLC 510(k) NO: K153636(Traditional) ATTN: KURT SCHNEIDER PHONE NO : 509 8513611 1426 EAST 3RD AVENUE SE DECISION MADE: 09-SEP-16 KENNEWICK WA 99336 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II ELITechGroup 510(k) NO: K153644(Traditional) ATTN: Valerie Gourdon PHONE NO : 330 233 812100 ZONE INDUSTRIELLE SE DECISION MADE: 07-SEP-16 Sees FR 61500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sentry WEB SmartInterp CareFusion Germany 234 GmbH 510(k) NO: K153654(Traditional) ATTN: Elmar Niedermeyer PHONE NO : 49 931 4972361 Leibnizstrasse 7 SE DECISION MADE: 16-SEP-16 Hoechberg DE 97204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: StealthStation System with Cranial Software MEDTRONIC NAVIGATION, INC. 510(k) NO: K153660(Traditional) ATTN: Augusta Henao PHONE NO : 720 8903366 826 COAL CREEK CIRCLE SE DECISION MADE: 14-SEP-16 LOUSVILLE CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROW FUSION-L NLT SPINE LTD 510(k) NO: K153665(Traditional) ATTN: Eti Zinger PHONE NO : 972 3 6344514 6 YAD HARUTZIM ST. SE DECISION MADE: 15-SEP-16 KFAR-SABA IL 4464103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEON III GENOSS CO., LTD. 510(k) NO: K153676(Traditional) ATTN: EUNSANG LEE PHONE NO : 82 70 70987568 1F GYEONGGI R&DB CENTER, 105 GWANGSE DECISION MADE: 14-SEP-16 SUWON-SI KR 433-270 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULYSS Multi View Sinuscope SOPRO-COMEG GMBH 510(k) NO: K153701(Traditional) ATTN: HAROLD LETTAU PHONE NO : 011 49 7461934429 DORNIERSTRASSE 55 SE DECISION MADE: 09-SEP-16 TUTTLINGEN DE 78532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROcedure Rehearsal Studio 3DSYSTEMS, SIMBIONIX PRODUCTS 510(k) NO: K153705(Special) ATTN: KIM TORLUEMKE PHONE NO : 972 391 14444 BEIT GOLAN CORNER OF GOLAN AND HANSE DECISION MADE: 02-SEP-16 AIRPORT CITY IL 70151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nihon Kohden Vital Sign Telemeter NIHON KOHDEN CORPORATION 510(k) NO: K153707(Traditional) ATTN: TOM BENTO PHONE NO : 949 6809048 1-31-4 NISHIOCHIAI, SHINJUKU-KU SE DECISION MADE: 02-SEP-16 TOKYO JP 161-8560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTICOAT Surgical Dressing Smith & Nephew Medical Limited 510(k) NO: K153723(Traditional) ATTN: Samantha Neilson PHONE NO : 44 1482 673790 101 Hessle Road SE DECISION MADE: 14-SEP-16 Hull GB HU3 2BN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VORTRAN Manometer VORTRAN MEDICAL TECHNOLOGY 1, INC.510(k) NO: K153733(Traditional) ATTN: JAMES LEE PHONE NO : 916 6488460 15 21 GOLDENLAND COURT, #100 SE DECISION MADE: 16-SEP-16 SACRAMENTO CA 95834 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Emergency Transtracheal Airway Catheter COOK INCORPORATED 510(k) NO: K153761(Traditional) ATTN: KOTEI AOKI PHONE NO : 812 3353575 102630 750 DANIELS WAY SE DECISION MADE: 22-SEP-16 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TXM Guiding Sheath Texas Medical Technologies, Inc. 510(k) NO: K153771(Traditional) ATTN: Aaron Chiu PHONE NO : 915 7744321 9005 Montana Ave., Suite A SE DECISION MADE: 13-SEP-16 El Paso TX 79925 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pure Vu Motus GI Medical Technologies Ltd.510(k) NO: K160015(Traditional) ATTN: Hagit Ephrath PHONE NO : 972 52 3142045 22 Keren Ha'yesod St. SE DECISION MADE: 22-SEP-16 Tirat Carmel IL 3902638 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Electronic Stethoscope DS301 IMEDIPLUS INC. 510(k) NO: K160023(Traditional) ATTN: SHIRLEY LAI PHONE NO : 886 3 6587700 2F, 12, SHENGYI RD.SEC.2 SE DECISION MADE: 30-SEP-16 CHUBEI CITY TW 30261 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pro-Link® Stand-Alone Cervical Spacer System Life Spine, Inc. 510(k) NO: K160066(Traditional) ATTN: Randy Lewis PHONE NO : 847 8846117 13951 S. Quality Drive SE DECISION MADE: 02-SEP-16 Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AbClose - Port Site Closure Device Medeon Biodesign, Inc 510(k) NO: K160117(Traditional) ATTN: GRETA CHANG PHONE NO : 886 2 28816686 306 7F, 116, HouGang St SE DECISION MADE: 09-SEP-16 Taipei TW 11170 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Flowable Wound Matrix COOK BIOTECH INCORPORATED 510(k) NO: K160136(Traditional) ATTN: PERRY W. GUINN PHONE NO : 765 4973355 1425 INNOVATION PLACE SE DECISION MADE: 28-SEP-16 WEST LAFAYETTE IN 47906 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTRIa series HDX WILL CORP. 510(k) NO: K160140(Traditional) ATTN: Hyung-suk Oh PHONE NO : 82 437 107318 #105, 201, 202, 203, 204, 38 OSONGSE DECISION MADE: 30-SEP-16 Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Active-X Total Knee System Signature Orthopaedics Pty Ltd. 510(k) NO: K160159(Traditional) ATTN: Declan Brazil PHONE NO : 61 2 94285181 7 Sirius Road SE DECISION MADE: 06-SEP-16 Lane Cove AU 2066 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DePuy Synthes TFNA Augmentation System Synthes (USA) Products, LLC 510(k) NO: K160167(Traditional) ATTN: Christopher J. Medberry PHONE NO : 610 7196806 1301 Goshen Parkway SE DECISION MADE: 26-SEP-16 West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLANTIS ISUS Implant Suprastructures DENTSPLY INTERNATIONAL, INC. 510(k) NO: K160207(Traditional) ATTN: HELEN LEWIS PHONE NO : 717 4871332 221 WEST PHILADELPHIA ST. SUITE 60SE DECISION MADE: 21-SEP-16 YORK PA 17401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Implance Dental Implant System, Implance Dental Abutment System AGS Medikal Urunleri Ith. Ihr. Tic510(k) NO: K160221(Traditional) ATTN: Gorkem Serce PHONE NO : 0090 216 5460078 Mahmut Yesari Caddesi No: 25 SE DECISION MADE: 12-SEP-16 Istanbul TR 34718 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HBOTC Muscle and Nerve Stimulator HB MEDICAL, INC. 510(k) NO: K160255(Traditional) ATTN: RYAN HEANEY PHONE NO : 714 8430463 5702 BOLSA AVENUE SE DECISION MADE: 15-SEP-16 HUNTINGTON BEACH CA 92649 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, Institut Straumann AG 510(k) NO: K160262(Traditional) ATTN: Christopher Klaczyk PHONE NO : 41 61 9651260 Peter Merian Weg 12 SE DECISION MADE: 16-SEP-16 Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Surgical Face Masks (Ear loops and Tie-on) SAN-M PACKAGE CO., LTD. 510(k) NO: K160269(Abbreviated) ATTN: Shogo Nagao PHONE NO : 011 81 547454125 1086-1 Ojiro SE DECISION MADE: 06-SEP-16 Shimada-City JP 428-8652 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Hi bebe plus BISTOS CO., LTD. 510(k) NO: K160274(Traditional) ATTN: Jenny Cho PHONE NO : 82 31 7500340 7th Fl., A Bldg., Woolim Lions ValSE DECISION MADE: 01-SEP-16 Seongnam KR 13201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Colposcope System XUZHOU KERNEL MEDICAL EQUIPMENT CO510(k) NO: K160341(Traditional) ATTN: JING WANG PHONE NO : 86 516 87732208 KERNEL MANSION, ECONOMIC DEVELOPMESE DECISION MADE: 14-SEP-16 XUZHOU CN 221004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System Infopia Co., Ltd. 510(k) NO: K160365(Special) ATTN: NA YUN KIM PHONE NO : 82 31 4600415 132, Anyangcheondong-ro, Dongan-guSE DECISION MADE: 28-SEP-16 Anyang KR 14040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head Dental Savings Club 510(k) NO: K160410(Traditional) ATTN: Chadi Saade PHONE NO : 514 7686879 31 Serge Garant SE DECISION MADE: 29-SEP-16 Montreal CA h3E 0A6 510(k) STATEMENT DEVICE: Sterling 5W Diode Laser CAO Group, Inc. 510(k) NO: K160413(Traditional) ATTN: Robert K Larsen PHONE NO : 801 2569282 4628 West Skyhawk Drive SE DECISION MADE: 21-SEP-16 West Jordan UT 84084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Perineologic Access Needle Corbin Clinical Resources, LLC 510(k) NO: K160423(Traditional) ATTN: Kenneth K. Kleinhenz PHONE NO : 858 4580994 12234 Williams Road SE DECISION MADE: 02-SEP-16 Cumberland MD 21502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BC-5390 Auto Hematology Analyzer MINDRAY BIO-MEDICAL ELECTRONICS CO510(k) NO: K160429(Traditional) ATTN: Min Zheng PHONE NO : MINDRAY BUILDING, KEJI 12TH RD SOUSE DECISION MADE: 01-SEP-16 NANSHAN CN 518057 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CreoDent Solidex Custom Abutment CreoDent Prosthetics, Ltd. 510(k) NO: K160436(Traditional) ATTN: Calvin Shim PHONE NO : 212 3023860 29 West 30th Street, 11th Floor SE DECISION MADE: 29-SEP-16 New York NY 10001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TempoCem Clear DMG USA, INC. 510(k) NO: K160443(Traditional) ATTN: Gordon Craig PHONE NO : 508 2265660 23 FRANK MOSSBERG DRIVE SE DECISION MADE: 30-SEP-16 ATTLEBORO MA 02703 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm Salvin Dental Specialties 510(k) NO: K160493(Traditional) ATTN: Jennifer Singer PHONE NO : 704 4425400 3450 Latrobe Drive SE DECISION MADE: 08-SEP-16 Charlotte NC 28211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pledgeted COR-SUTURE QUICK LOAD LSI SOULTIONS 510(k) NO: K160529(Abbreviated) ATTN: KEVIN BENTLEY PHONE NO : 585 8696669 7796 VICTOR-MENDON RD SE DECISION MADE: 15-SEP-16 VICTOR NY 14564 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Noiselezz FIRMA INGEMARSSON 510(k) NO: K160531(Abbreviated) ATTN: Natashia Ingemarsson-MatzenPHONE NO : 45 36 177050 VILVORDEVEJ 61 SE DECISION MADE: 01-SEP-16 CHARLOTTENLUND DK 2920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Enseal X1 Large Jaw Tissue Sealer ETHICON ENDO-SURGERY, LLC 510(k) NO: K160554(Traditional) ATTN: DAVID LOCKE PHONE NO : 513 3371281 4545 CREEK RD SE DECISION MADE: 09-SEP-16 CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CareSens Pen Needle, Softip Pen Needle YIDOBIO INC. 510(k) NO: K160575(Traditional) ATTN: KYUNG HEE YOON PHONE NO : 82 31 3525035 #3-1, 59-12, DONG4-GIL, HYANGNAM-ESE DECISION MADE: 07-SEP-16 HWASEONG-SI KR 18624 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WiCap Athena GTX 510(k) NO: K160582(Abbreviated) ATTN: Sean Mahoney PHONE NO : 515 2883360 103 5900 NW 86th Street, Suite 300 SE DECISION MADE: 02-SEP-16 Johnston IA 50131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Indy OTW Vascular Retriever COOK INCORPORATED 510(k) NO: K160593(Traditional) ATTN: Chad Schulenburg PHONE NO : 812 3353575 104073 750 DANIELS WAY SE DECISION MADE: 02-SEP-16 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BC-5D Hematology Control R & D SYSTEMS, INC. 510(k) NO: K160606(Traditional) ATTN: RAVI KOMMINENI PHONE NO : 612 6564463 614 MCKINLEY ST NE SE DECISION MADE: 01-SEP-16 MINNEAPOLIS MN 55413 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Invacare Platinum Mobile Oxygen Concentrator INVACARE CORPORATION 510(k) NO: K160630(Traditional) ATTN: ELIJAH N. WREH PHONE NO : 440 3296840 ONE INVACARE WAY SE DECISION MADE: 27-SEP-16 ELYRIA OH 44035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASS XS Spinal System MEDICREA INTERNATIONAL S.A. 510(k) NO: K160640(Traditional) ATTN: David Ryan PHONE NO : 33 472 018787 14 PORTE DU GRAND LYON SE DECISION MADE: 23-SEP-16 NEYRON FR 01700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube BECTON, DICKINSON AND COMPANY 510(k) NO: K160657(Traditional) ATTN: Branden Reid PHONE NO : 201 8477378 1 BECTON DRIVE SE DECISION MADE: 23-SEP-16 FRANKLIN LAKES NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LigaPASS MEDICREA INTERNATIONAL S.A. 510(k) NO: K160698(Traditional) ATTN: DAVID RYAN PHONE NO : 33 472 018787 14 PORTE DU GRAND LYON SE DECISION MADE: 02-SEP-16 NEYRON FR 01700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves Haylard Health 510(k) NO: K160709(Abbreviated) ATTN: Gwendolyn George PHONE NO : 520 6642822 5405 Windward Parkway SE DECISION MADE: 06-SEP-16 Alpharetta GA 30004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K160724(Traditional) ATTN: KATHLEEN DRAY-LYONS PHONE NO : 781 8264551 500 GBC DRIVE SE DECISION MADE: 07-SEP-16 NEWARK DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NutraStim Hair Laser Helmet NUTRA LUXE MD LLC 510(k) NO: K160728(Traditional) ATTN: GLORIA AVENDANO PHONE NO : 239 5619699 12801 COMMONWEALTH DR. UNIT 2-6 SE DECISION MADE: 16-SEP-16 FORT MYERS FL 33976 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CATSmart FRESENIUS KABI AG 510(k) NO: K160735(Traditional) ATTN: Barry G. Hicks PHONE NO : 49 6172 6860 ELSE-KRONER-STRASSE 1 SE DECISION MADE: 16-SEP-16 Bad Homburg DE 61352 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) VENCLOSE, INC. 510(k) NO: K160754(Traditional) ATTN: MAI LY WILCOX PHONE NO : 415 2541930 2570 N. 1ST., 2ND FL #221 SE DECISION MADE: 09-SEP-16 SAN JOSE CA 95131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Procellera VOMARIS INNOVATIONS, INC. 510(k) NO: K160783(Traditional) ATTN: Timothy Joiner PHONE NO : 480 9214948 1911 E. 5TH ST SE DECISION MADE: 07-SEP-16 Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAM Titanium Blanks ALTATEC GMBH 510(k) NO: K160784(Traditional) ATTN: COLLEEN BOSWELL PHONE NO : 49 7044 94450 MAYBACHSTRASSE 5 SE DECISION MADE: 14-SEP-16 WIMSHEIM DE D-71299 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) NEXMED TECHNOLOGY CO., LTD 510(k) NO: K160816(Traditional) ATTN: Ellen Xu PHONE NO : 86 755 29481701 2 FLOOR OF NO.1 BUILDING, JIA AN SE DECISION MADE: 21-SEP-16 Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERRAD® NX Sterilizer with ALLClear™ Technology ADVANCED STERILIZATION PRODUCTS 510(k) NO: K160818(Traditional) ATTN: Jamie Byun PHONE NO : 949 7882067 33 Technology Drive SE DECISION MADE: 27-SEP-16 Irvine CA 92617 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV RESMED LTD 510(k) NO: K160822(Traditional) ATTN: JASJIT BAVEJA PHONE NO : 61 88841000 1 ELIZABETH MACARTHUR DRIVE SE DECISION MADE: 09-SEP-16 BELLA VISTA AU 2153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology DENTSPLY SIRONA 510(k) NO: K160825(Traditional) ATTN: Helen Lewis PHONE NO : 717 4871332 221 WEST PHILADELPHIA STREET SUITESE DECISION MADE: 27-SEP-16 York PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Dentium Implantium & SuperLine Prosthetics DENTIUM CO., LTD. 510(k) NO: K160828(Abbreviated) ATTN: Sangpil Yoon PHONE NO : 82 312 072200 150, EONDONG-RO, GIHEUNG-GU SE DECISION MADE: 15-SEP-16 Yongin-si KR 443-270 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MiniMed Quick-serter MEDTRONIC MINIMED 510(k) NO: K160860(Traditional) ATTN: Noreen Bajwa PHONE NO : 818 5765224 18000 DEVONSHIRE STREET SE DECISION MADE: 22-SEP-16 NORTHRIDGE CA 91325 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AirStrip RPM AirStrip Technologies, Inc. 510(k) NO: K160862(Traditional) ATTN: Andy Miller PHONE NO : 335 E. Sonterra Blvd, Suite 200 SE DECISION MADE: 19-SEP-16 San Antonio TX 78258 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Pavati Z40.2 Zirconia CCRI, INC. 510(k) NO: K160867(Traditional) ATTN: ROBIN CARDEN PHONE NO : 949 3665221 1319 CALLE AVANZADO SE DECISION MADE: 12-SEP-16 SAN CLEMENTE CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Photonica Professional Ward Photonics LLC 510(k) NO: K160880(Traditional) ATTN: Terry Ward PHONE NO : 800 3925950 1980 N Atlantic Avenue SE DECISION MADE: 23-SEP-16 Cocoa Beach FL 32931 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERRAD 100NX Sterilizer with ALLClearTM Technology ADVANCED STERILIZATION PRODUCTS 510(k) NO: K160903(Traditional) ATTN: JAMIE BYUN PHONE NO : 949 7882067 33 TECHNOLOGY DRIVE SE DECISION MADE: 26-SEP-16 Irvine CA 92617 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Hansen Medical Magellan Robotic Catheter 9Fr HANSEN MEDICAL, INC. 510(k) NO: K160919(Traditional) ATTN: MARYSA LOUSTALOT PHONE NO : 650 4045824 800 E MIDDLEFIELD ROAD SE DECISION MADE: 20-SEP-16 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Endophys Blood Pressure Monitor ENDOPHYS HOLDINGS, LLC 510(k) NO: K160945(Traditional) ATTN: Rebecca K. Pine PHONE NO : 760 8095178 1601 ELM STREET SE DECISION MADE: 26-SEP-16 Dallas TX 75201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CDB Self Ligating Bracket 8F CDB CORPORATION 510(k) NO: K160957(Traditional) ATTN: YANNIRE THOMPSON PHONE NO : 910 3836464 9201 INDUSTRIAL BOULEVARD, NE SE DECISION MADE: 27-SEP-16 LELAND NC 28451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Battalion Universal Spacer System ALPHATEC SPINE 510(k) NO: K160958(Traditional) ATTN: MARY FUNK PHONE NO : 760 4946840 5818 EL CAMINO REAL SE DECISION MADE: 08-SEP-16 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Neodent Implant System - Titanium Base for CEREC JJGC INDUSTRIA E COMERCIO DE MATER510(k) NO: K160964(Traditional) ATTN: JACSON Cambruzzi PHONE NO : 55 412 1694058 AV. JUSCELINO KUBITSCHEK DE OLIVEISE DECISION MADE: 16-SEP-16 CURITIBA BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Aprima Smartesis Centesis Pump COOK INCORPORATED 510(k) NO: K161002(Traditional) ATTN: ERUM B. NASIR PHONE NO : 812 3353575 102607 750 DANIELS WAY SE DECISION MADE: 28-SEP-16 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Self-retaining Retractor FETZER MEDICAL GMBH & CO.KG 510(k) NO: K161004(Traditional) ATTN: Harald Jung PHONE NO : 49 7462 94799182 UNTER BUCHSTEIG 5 SE DECISION MADE: 09-SEP-16 Tuttlingen DE 78532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NuVasive® Reline® System NUVASIVE, INCORPORATED 510(k) NO: K161014(Special) ATTN: Thao Huynh PHONE NO : 858 3205256 7475 LUSK BOULEVARD SE DECISION MADE: 28-SEP-16 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Profound System SYNERON CANDELA CORPORATION 510(k) NO: K161043(Traditional) ATTN: Ruthie Amir PHONE NO : 508 3587400 330 530 BOSTON POST ROAD SE DECISION MADE: 12-SEP-16 Wayland MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: All-Bond Universal w/BAC (not finalized) Bisco, Inc. 510(k) NO: K161051(Traditional) ATTN: Ryan Hobson PHONE NO : 847 5346143 1100 West Irving Park Road SE DECISION MADE: 09-SEP-16 Schaumburg IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EzRay Air (Model VEX-P300) Vatech Co., Ltd 510(k) NO: K161063(Traditional) ATTN: Daniel Kim PHONE NO : 82 31 3799492 13, Samsung 1-ro 2-gil SE DECISION MADE: 01-SEP-16 Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” EGINEERED TISSUE SOLUTIONS, LLC 510(k) NO: K161067(Traditional) ATTN: Mark Borden PHONE NO : 573 4585966 4030 HYPOINT NORTH SE DECISION MADE: 15-SEP-16 Rolla MO 65401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ahead 300 BRAINSCOPE COMPANY INC 510(k) NO: K161068(Traditional) ATTN: Michael Singer PHONE NO : 240 7527677 4350 East West Highway Suite 1050 SE DECISION MADE: 22-SEP-16 Bethesda MD 20814 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SeaSpine Shoreline ACS - Anterior Cervical Standalone System SEASPINE ORTHOPEDICS CORPORATION 510(k) NO: K161081(Traditional) ATTN: Michelle Willis PHONE NO : 760 2165104 5770 ARMADA DRIVE SE DECISION MADE: 14-SEP-16 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) Sterilmed, Inc. 510(k) NO: K161086(Traditional) ATTN: Patricia Kaufman PHONE NO : 763 4883211 5010 Cheshire Parkway, Suite 2 SE DECISION MADE: 20-SEP-16 Plymouth MN 55446 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KARL STORZ Flexible Video-Neuro-Endoscope System KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K161112(Traditional) ATTN: SUSIE S. CHEN PHONE NO : 424 2188201 2151 E. GRAND AVENUE SE DECISION MADE: 17-SEP-16 EL SEGUNDO CA 90245 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PILLAR SA PTC ORTHOFIX INC. 510(k) NO: K161129(Traditional) ATTN: Natalia Volosen PHONE NO : 214 9372145 3451 PLANO PARKWAY SE DECISION MADE: 08-SEP-16 LEWISVILLE TX 75056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Spinal fixation system CANWELL MEDICAL CO., LTD. 510(k) NO: K161151(Traditional) ATTN: CHEN HUI PHONE NO : 86 579 89008253 NO. 466 SOUTH XIANHUA STREET,HIGH-SE DECISION MADE: 21-SEP-16 JINHUA CN 321016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra ELLIPSE A/S 510(k) NO: K161162(Traditional) ATTN: OLE KOFOD PHONE NO : 45 4 5176863 AGERN ALLE 11 SE DECISION MADE: 16-SEP-16 HOERSHOLM DK DK-2970 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Next Science Irrigation Solution NEXT SCIENCE, LLC 510(k) NO: K161165(Traditional) ATTN: MATTHEW MYNTTI PHONE NO : 855 5642762 8130 BAYMEADOWS WAY WEST, SUITE 20SE DECISION MADE: 07-SEP-16 JACKSONVILLE FL 33256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: StageOne Select Cement Spacer Molds for Temporary Hip Replacement BIOMET, INC. 510(k) NO: K161166(Traditional) ATTN: Carmen Albany PHONE NO : 574 3713024 56 EAST BELL DRIVE SE DECISION MADE: 08-SEP-16 Warsaw IN 46581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MyLabSix Ultrasound System Esaote Europe B.V. 510(k) NO: K161168(Traditional) ATTN: Bert Vorstenbosch PHONE NO : 011 31 433824600 Philipsweg 1 SE DECISION MADE: 02-SEP-16 Maastricht NL 6227 AJ 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Avenue® T TLIF Cage LDR SPINE USA, INC. 510(k) NO: K161173(Traditional) ATTN: JOHN ROSSMAN PHONE NO : 512 7958306 13785 RESEARCH BLVD, SUITE 200 SE DECISION MADE: 28-SEP-16 AUSTIN TX 78750 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUCERNA Dental Laser VIAX DENTAL LAB 510(k) NO: K161185(Traditional) ATTN: EDWIN M. FIRST PHONE NO : 949 6333554 CALLE POTRERILLOS, FLEXIPARK BODSE DECISION MADE: 26-SEP-16 ALAJUELA CR 20108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs ECO MEDI GLOVE SDN BHD 510(k) NO: K161187(Traditional) ATTN: Suresh Kumar PHONE NO : 603 60283033 Lot 23826, Jalan TEmbaga Kuning, KSE DECISION MADE: 09-SEP-16 Taiping MY 34600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ClearRead CT RIVERAIN TECHNOLOGIES, LLC 510(k) NO: K161201(Traditional) ATTN: Jennifer Butsch PHONE NO : 937 4256811 3020 SOUTH TECH BLVD. SE DECISION MADE: 09-SEP-16 Miamisburg OH 45324 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Atteris Antimicrobial Skin Protectant ROCHAL INDUSTRIES LLC 510(k) NO: K161212(Traditional) ATTN: William J. Coulston PHONE NO : 210 8706534 12719 CRANES MILL SE DECISION MADE: 30-SEP-16 SAN ANTONIO TX 78230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit HALYARD HEALTH 510(k) NO: K161232(Traditional) ATTN: GWENDOLYN GEORGE PHONE NO : 520 2046442 5405 WINDWARD PARKWAY SE DECISION MADE: 30-SEP-16 ALPHARETTA GA 30004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MTA2.2 MATERIAL AVALON BIOMED INC. 510(k) NO: K161239(Traditional) ATTN: CAROLYN PRIMUS PHONE NO : 941 8969948 1912 44TH AVE E SE DECISION MADE: 01-SEP-16 BRADENTON FL 34203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Super Distal Access (SDA) INNEUROCO, INC 510(k) NO: K161262(Traditional) ATTN: Marc Litzenberg PHONE NO : 954 4725988 4635 NW 103RD AVENUE SE DECISION MADE: 19-SEP-16 Sunrise FL 33351 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OptoMonitor II Opsens Inc 510(k) NO: K161263(Traditional) ATTN: Vanessa Mootoosamy PHONE NO : 418 781 03333401 750, Boulevard du Parc TechnologiqSE DECISION MADE: 13-SEP-16 Quebec CA GIP 4S3 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Compound W Wart Removal System Dual Power MEDTECH PRODUCTS INC. 510(k) NO: K161294(Traditional) ATTN: JEAN BOYKO PHONE NO : 914 5246894 660 WHITE PLAINS ROAD SE DECISION MADE: 15-SEP-16 Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sysmex Automated Blood Coagulation Analyzer CS-2100i SIEMENS HEALTHCARE DIAGNOSTICS PRO510(k) NO: K161312(Traditional) ATTN: NILS NEUMANN PHONE NO : 49 64 21397133 EMIL-VON-BEHRING-STR. 76 SE DECISION MADE: 01-SEP-16 MARBURG DE 35041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sysmex Automated Blood Coagulation Analyzer CS-5100 Siemens Healthcare Diagnostics Pro510(k) NO: K161317(Traditional) ATTN: Nils Neumann PHONE NO : 49 642 1397133 Emil-von-Behring-Str. 76 SE DECISION MADE: 02-SEP-16 Marburg DE 35041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMG Pink Nitrile Examination Glove Powder Free ECO MEDI GLOVE SDN. BHD. 510(k) NO: K161320(Traditional) ATTN: Suresh Kumar PHONE NO : 60 3 60283033 LOT 23826, JALAN TEMBAGA KUNING, SE DECISION MADE: 01-SEP-16 TAIPING MY 34600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GentleCath Glide Intermittent Catheter CONVATEC LIMITED 510(k) NO: K161344(Traditional) ATTN: ELINOR JONES PHONE NO : 44 01244 854176 GDC, FIRST AVENUE, DEESIDE INDUSTRSE DECISION MADE: 20-SEP-16 DEESIDE GB CH5 2NU 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Signia sterilization tray COVIDIEN 510(k) NO: K161347(Traditional) ATTN: KATHERINE Y. CHOI PHONE NO : 203 4928412 60 MIDDLETOWN AVENUE SE DECISION MADE: 07-SEP-16 NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Matrix LS-40 CO2 Laser System SHANGHAI WONDERFUL OPTO-ELECTRICS 510(k) NO: K161356(Traditional) ATTN: Amy Lee PHONE NO : 86 21 62642623 2F, BUILDING 3 LANE 561, NUJIANG RSE DECISION MADE: 09-SEP-16 SHANGHAI CN 200333 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) Agfa HealthCare N.V. 510(k) NO: K161368(Traditional) ATTN: Koen Vervoort PHONE NO : 32 3 4447368 Septestraat 27 SE DECISION MADE: 22-SEP-16 Mortsel BE B-2640 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELSA Spacers GLOBUS MEDICAL, INC. 510(k) NO: K161379(Traditional) ATTN: KELLY J. BAKER PHONE NO : 610 9301800 1670 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 29-SEP-16 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable Shockwave Medical, Inc. 510(k) NO: K161384(Traditional) ATTN: NORA HADDING PHONE NO : 510 2793068 48501 Warm Springs Blvd, Suite 108SE DECISION MADE: 14-SEP-16 Fremont CA 94539 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Elation Pulmonary Balloon Dilation MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K161392(Traditional) ATTN: DAVID THOMAS PHONE NO : 801 3164956 1600 WEST MERIT PARKWAY SE DECISION MADE: 01-SEP-16 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Navident ClaroNav Inc. 510(k) NO: K161406(Traditional) ATTN: Doron Dekel PHONE NO : 647 9511525 1140 Sheppard Avenue West, Unit 10SE DECISION MADE: 08-SEP-16 Toronto CA M3K 2A2 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Phasix Mesh C.R. BARD INC. 510(k) NO: K161424(Traditional) ATTN: JANNA BABSON PHONE NO : 401 8258454 100 CROSSINGS BOULEVARD SE DECISION MADE: 29-SEP-16 WARWICK RI 02886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-CUBE 11 ALPINION MEDICAL SYSTEMS CO., LTD.510(k) NO: K161439(Traditional) ATTN: DONGHWAN KIM PHONE NO : 82 70 74652068 1FL AND 6FL VERDI TOWER, 72, DIGITSE DECISION MADE: 21-SEP-16 SEOUL KR 08393 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NuVasive® CoRoent® Small Interlock™ System NUVASIVE INCORPORATED 510(k) NO: K161442(Traditional) ATTN: Cynthia Adams PHONE NO : 858 320 4549 7475 LUSK BOULEVARD SE DECISION MADE: 28-SEP-16 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Biopor Porous Polyethylene Implants Ceremed , Inc. 510(k) NO: K161446(Traditional) ATTN: Chelsea Mitchell PHONE NO : 310 8152125 3643 Lenawee Ave SE DECISION MADE: 27-SEP-16 Los Angeles CA 90016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIB Stent Placement Catheter NUMED, INC. 510(k) NO: K161451(Traditional) ATTN: Nichelle LaFlesh PHONE NO : 315 3284491 2880 MAIN ST. SE DECISION MADE: 22-SEP-16 HOPKINTON NY 12965 510(k) STATEMENT DEVICE: Catalys Precision Laser System Optimedica Corporation 510(k) NO: K161455(Traditional) ATTN: Ankur Kaushal PHONE NO : 408 7928207 1310 Moffet Park Drive SE DECISION MADE: 20-SEP-16 Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) VARIAN MEDICAL SYSTEMS, X-RAY PROD510(k) NO: K161459(Traditional) ATTN: Catherine Mulcahy PHONE NO : 315 2346800 121 METROPOLITAN DRIVE SE DECISION MADE: 06-SEP-16 LIVERPOOL NY 13088 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters Innovative Health, LLC 510(k) NO: K161464(Traditional) ATTN: Rafal Chudzik PHONE NO : 480 5256006 1435 North Hayden Road, Suite 100 SE DECISION MADE: 30-SEP-16 Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CardioConfirm MORTARA INSTRUMENT, INC. 510(k) NO: K161465(Traditional) ATTN: Margaret Mucha PHONE NO : 414 3541600 7865 NORTH 86TH STREET SE DECISION MADE: 03-SEP-16 Milwaukee WI 53224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Xenco Medical Posterior Cervical System Xenco Medical, LLC 510(k) NO: K161478(Traditional) ATTN: Gustavo Prado PHONE NO : 858 2021505 9930 Mesa Rim Road SE DECISION MADE: 06-SEP-16 San Diego CA 92121 510(k) STATEMENT DEVICE: Nanovis Intervertebral Body Fusion System and Forticore(R) NANOVIS LLC 510(k) NO: K161485(Traditional) ATTN: MATTHEW HEDRICK PHONE NO : 877 9076266 5865 EAST STATE RD. 14 SE DECISION MADE: 06-SEP-16 COLUMBIA CITY IN 46725 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VPAP Adapt SV, VPAP Tx, S9 VPAP Tx ResMed Ltd 510(k) NO: K161487(Traditional) ATTN: Jasjit Baveja PHONE NO : 61 2 88841518 1 Elizabeth Macarthur Drive SE DECISION MADE: 09-SEP-16 Bella Vista AU NSW 2153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Syntorr K-wire and Pin System SYNTORR INC 510(k) NO: K161489(Traditional) ATTN: DANIEL MARTIN PHONE NO : 650 8670367 1157 HARKER AVENUE SE DECISION MADE: 16-SEP-16 PALO ALTO CA 94301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Penumbra Aspiration System Penumbra, Inc. 510(k) NO: K161506(Traditional) ATTN: Richard Kimura PHONE NO : 510 9952034 1 Penumbra Place SE DECISION MADE: 26-SEP-16 Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NeuroStar TMS Therapy System NEURONETICS, INC. 510(k) NO: K161519(Traditional) ATTN: JUDY P. WAYS PHONE NO : 610 6404202 3222 PHOENIXVILLE PIKE SE DECISION MADE: 11-SEP-16 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Tangis Anterior Cervical Plate NVISION BIOMEDICAL TECHNOLOGIES, L510(k) NO: K161524(Traditional) ATTN: DIANA L. LANGHAM PHONE NO : 210 5453713 1350 N LOOP 1604 E, SUITE 103 SE DECISION MADE: 02-SEP-16 SAN ANTONIO TX 78232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SeaSpine® NewPort™ Spinal System SEASPINE ORTHOPEDICS CORPORATION 510(k) NO: K161535(Traditional) ATTN: Michelle Willis PHONE NO : 760 2165104 5770 ARMADA DRIVE SE DECISION MADE: 08-SEP-16 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TR-100 BTL INDUSTRIES, INC. 510(k) NO: K161551(Traditional) ATTN: Jan Zarsky PHONE NO : 866 2851656 47 LORING DRIVE SE DECISION MADE: 13-SEP-16 FRAMINGHAM MA 01702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sound Options Tinnitus Treatment Sound Options Tinnitus Treatments 510(k) NO: K161562(Traditional) ATTN: Michael Chrostowski PHONE NO : 416 8015356 3841 Ridgepoint Way SE DECISION MADE: 28-SEP-16 Mississauga CA L5N 7T7 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUO STETIC MEDICAL AESTHETICS DEVELOPM510(k) NO: K161565(Traditional) ATTN: Juan Ye PHONE NO : 86 755 61218197 10-11th Floor, Bensi Building, NewSE DECISION MADE: 01-SEP-16 Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGNA Voyager GE HEALTHCARE 510(k) NO: K161567(Traditional) ATTN: Glen Sabin PHONE NO : 262 5216848 3200 N. GRANDVIEW BLVD SE DECISION MADE: 01-SEP-16 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Bone Solutions Mixing and Delivery System BONE SOLUTIONS, INC. 510(k) NO: K161568(Traditional) ATTN: DREW DIAZ PHONE NO : 817 8098850 5712 COLLEYVILLE BLVD, SUITE 210 SE DECISION MADE: 16-SEP-16 COLLEYVILLE TX 76034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FilmArray RP EZ Control Panel M265 MAINE MOLECULAR QUALITY CONTROLS, 510(k) NO: K161573(Traditional) ATTN: JOAN GORDON PHONE NO : 207 8851072 23 MILL BROOK ROAD SE DECISION MADE: 02-SEP-16 SACO ME 04072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Arthrex Synergy RF System ARTHREX, INC. 510(k) NO: K161581(Traditional) ATTN: William Heard PHONE NO : 239 6435553 71813 1370 Creekside Blvd SE DECISION MADE: 09-SEP-16 Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Mano and Mano Personal Lubricant Mano and Mano Proprietary Limited 510(k) NO: K161585(Traditional) ATTN: Katrina Allen PHONE NO : 613 9555 1318 286 Chesterville Road SE DECISION MADE: 06-SEP-16 Moorabbin AU 3189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments GLOBUS MEDICAL INC. 510(k) NO: K161591(Traditional) ATTN: Kelly J. Baker PHONE NO : 610 9301800 1670 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 21-SEP-16 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Resection Electrodes OLYMPUS WINTER & IBE GMBH 510(k) NO: K161600(Traditional) ATTN: Katharina Campbell PHONE NO : 49 406 69662997 KUEHNSTRASSE 61 SE DECISION MADE: 06-SEP-16 Hamburg DE 22045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Arctic Sun Temperature Management System Medivance, Inc. 510(k) NO: K161602(Special) ATTN: Stacci Cronk PHONE NO : 303 3215151 321 South Taylor Ave, Suite 200 SE DECISION MADE: 02-SEP-16 Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: InterForm Cervical Interbody Cage System NEXT ORTHOSURGICAL 510(k) NO: K161608(Traditional) ATTN: ELLEN YARNALL PHONE NO : 760 2953600 3270 CORPORATE VIEW SUITE A SE DECISION MADE: 30-SEP-16 Vista CA 92081 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PixelShine ALGOMEDICA 510(k) NO: K161625(Traditional) ATTN: Jagdish Vij PHONE NO : 650 7149944 2600 EL CAMINO REAL, SUITE 100 SE DECISION MADE: 19-SEP-16 Palo Alto CA 94306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Provicol QM Plus VOCO GMBH 510(k) NO: K161630(Traditional) ATTN: TH. PLAUMANN PHONE NO : 49 472 17190 ANTON-FLETTNER-STR. 1-3 SE DECISION MADE: 15-SEP-16 CUXHAVEN DE 27472 510(k) STATEMENT DEVICE: Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor AMBU A/S 510(k) NO: K161656(Special) ATTN: CAMILLA WISMAR PHONE NO : 45 7 2252000 BALTORPBAKKEN 13 SE DECISION MADE: 01-SEP-16 BALLERUP DK DK-2750 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Anexa Wound Flush, Sterile Water & Sterile Normal Saline ANEXA BIOMEDICAL, INC. 510(k) NO: K161658(Traditional) ATTN: LENNY BUDLOO PHONE NO : 813 7807927 40423 AIR TIME AVE SE DECISION MADE: 14-SEP-16 ZEPHYRHILLS FL 33542 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ponto 3, Ponto 3 Power and Ponto 3 SuperPower OTICON MEDICAL AB 510(k) NO: K161671(Traditional) ATTN: Satu Hjartstam PHONE NO : 46 735 449813 DATAVAGEN 37B SE DECISION MADE: 29-SEP-16 ASKIM SE SE-436 32 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SpeediCath Flex Coude Coloplast Corp. 510(k) NO: K161672(Traditional) ATTN: Rebecca S. Roberts PHONE NO : 612 3442373 1601 West River Road North SE DECISION MADE: 29-SEP-16 Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Madsen Zodiac GN OTOMETRICS 510(k) NO: K161707(Special) ATTN: Asif Muhammad PHONE NO : 847 5342150 Hoerskaetten 9 SE DECISION MADE: 01-SEP-16 Taatrup DK DK-2630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Personal Kinetigraph (PKG) System GKC MANUFACTURING PTY LTD. 510(k) NO: K161717(Traditional) ATTN: BRENDAN FAFIANI PHONE NO : 61 459 999582 LEVEL 15, 440 COLLINS ST SE DECISION MADE: 20-SEP-16 MELBOURNE AU 3000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set Diazyme Laboratories 510(k) NO: K161721(Traditional) ATTN: Abhijit Datta PHONE NO : 858 4554762 12889 Gregg Court SE DECISION MADE: 20-SEP-16 Poway CA 92130 510(k) STATEMENT DEVICE: Symmetry Sharp Kerrison Rongeur Symmetry Surgical Inc. 510(k) NO: K161744(Special) ATTN: Lora Tjomstol PHONE NO : 1 800 2513000 3034 Owen Drive SE DECISION MADE: 07-SEP-16 Antioch TN 37013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARIX Hand System Jeil Medical Corporation 510(k) NO: K161746(Special) ATTN: Seungyong Lee PHONE NO : 82 2 8503533 SE DECISION MADE: 21-SEP-16 Seoul KR 152-728 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGEC® Spinal Bracing and Distraction System NUVASIVE SPECIALIZED ORTHOPEDICS, 510(k) NO: K161751(Traditional) ATTN: REBECCA SHELBURNE WALKER PHONE NO : 949 8373600 101 ENTERPRISE, SUITE 100 SE DECISION MADE: 02-SEP-16 ALISO VIEJO CA 92656 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SyncVision System Volcano Corporation 510(k) NO: K161756(Traditional) ATTN: Elaine Alan PHONE NO : 858 7641281 3721 Valley Ctr. Dr. SE DECISION MADE: 05-SEP-16 San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Weck Auto Endo10 Automatic Endoscopic Clip Applier TELEFLEX MEDICAL 510(k) NO: K161758(Traditional) ATTN: HOLLY HALLOCK PHONE NO : 919 4334996 3015 CARRINGTON MILL BLVD SE DECISION MADE: 07-SEP-16 MORRISVILLE NC 27560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CG+ Arrow JACC ARROW INTERNATIONAL, INC. (SUBSIDI510(k) NO: K161765(Special) ATTN: JULIE LAWSON PHONE NO : 610 3780131 2400 BERNVILLE ROAD SE DECISION MADE: 06-SEP-16 READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: i-Sil SPIDENT Co., Ltd. 510(k) NO: K161774(Traditional) ATTN: J. M. Ahn PHONE NO : 82 32 8194570 203 & 312, Korea Indsutrial CompleSE DECISION MADE: 30-SEP-16 Incheon KR 21692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PINPOINT Endoscopic Fluorescence Imaging System Novadaq Technologies Inc. 510(k) NO: K161792(Special) ATTN: Jen Pendlebury PHONE NO : 905 6293822 205 8329 Eastlake Drive, Unit 101 SE DECISION MADE: 20-SEP-16 Burnaby CA V5A 4W2 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Traxcess .007 Mini Guidewire MICROVENTION, INC. 510(k) NO: K161803(Special) ATTN: SAPNA SINGH PHONE NO : 714 2478162 1311 VALENCIA AVENUE SE DECISION MADE: 30-SEP-16 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LigaSure Retractable L-Hook Laparoscopic Sealer/Divider COVIDIEN 510(k) NO: K161804(Traditional) ATTN: DAWN D. TINDALL PHONE NO : 303 5817034 5920 LONGBOW DRIVE SE DECISION MADE: 16-SEP-16 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Solana Influenza A+B Assay Quidel Corporation 510(k) NO: K161814(Traditional) ATTN: Ronald H. Lollar PHONE NO : 740 5893373 2005 East State Street, Suite 100 SE DECISION MADE: 27-SEP-16 Athens OH 45701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEM Premier 3000 Instrumentation Laboratory Co. 510(k) NO: K161818(Special) ATTN: Nikita Malladi PHONE NO : 781 6743245 180 Hartwell Road SE DECISION MADE: 14-SEP-16 Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PK AIM GYRUS ACMI INC. 510(k) NO: K161825(Traditional) ATTN: GRAHAM A.L. BAILLIE PHONE NO : 508 8042690 136 TURNPIKE ROAD SE DECISION MADE: 26-SEP-16 SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: O2VENT T OVENTUS MANUFACTURING PTY LTD 510(k) NO: K161832(Special) ATTN: HEMANGI MALDE PHONE NO : 61 7 31803196 1 SWANN ROAD SE DECISION MADE: 23-SEP-16 INDOOROOPILLY AU 4068 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Xenocor Xenoscope Laparoscopic System Xenocor, Inc 510(k) NO: K161838(Traditional) ATTN: Spencer Walker PHONE NO : 801 5815080 630 Komas Dr. Suite 200 SE DECISION MADE: 26-SEP-16 Salt Lake City UT 84108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K161843(Traditional) ATTN: PAUL BIGGINS PHONE NO : 714 6697808 1385 SHIMOISHIGAMI SE DECISION MADE: 21-SEP-16 OTAWARA-SHI JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BioFlo Midline Catheter NAVILYST MEDICAL, INC. 510(k) NO: K161866(Traditional) ATTN: ROBIN FULLER PHONE NO : 508 6587986 26 FOREST STREET SE DECISION MADE: 08-SEP-16 MARLBOROUGH MA 07152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LaserCap300, LaserCap224, LaserCap120, LaserCap80 TRANSDERMAL CAP, INC. 510(k) NO: K161875(Traditional) ATTN: MICHAEL RABIN PHONE NO : 440 2411846 938 CHESTNUT RUN SE DECISION MADE: 30-SEP-16 GATES MILLS OH 44040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Tritium® Sternal Cable Plate System Pioneer Surgical Technology, Inc. 510(k) NO: K161876(Special) ATTN: Sarah Pleaugh PHONE NO : 906 2269909 375 River Park Circle SE DECISION MADE: 09-SEP-16 Marquette MI 49855 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTAGE System Baylis Medical Company Inc. 510(k) NO: K161878(Traditional) ATTN: Meghal Khakhar PHONE NO : 905 6024875 2645 Matheson Blvd. East SE DECISION MADE: 26-SEP-16 Mississauga CA L4W 5S4 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Solitaire Platinum Revascularization Device Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K161879(Special) ATTN: Ryan Kenney PHONE NO : 949 2975489 9775 Toledo Way SE DECISION MADE: 21-SEP-16 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip Volcano Corporation 510(k) NO: K161887(Special) ATTN: Brian Park PHONE NO : 858 7204176 3721 Valley Centre Drive Suite 50SE DECISION MADE: 20-SEP-16 San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JULIET® LL Lateral Lumbar Cage SPINEART 510(k) NO: K161888(Special) ATTN: FRANCK PENNESI PHONE NO : 41 225 701246 INTERNATIONAL CENTER COINTRIN 20 RSE DECISION MADE: 12-SEP-16 Geneva CH 1215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 2MP Color LCD Monitor CCL214 (CL21214) JVC KENWOOD Corporation 510(k) NO: K161895(Traditional) ATTN: Tsukasa Tashiro PHONE NO : 81 258 246611 3-12, Moriya-cho, Kanagawa-ku SE DECISION MADE: 08-SEP-16 Yokohama JP 221-0022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant CHURCH & DWIGHT CO.,INC. 510(k) NO: K161915(Traditional) ATTN: Lisa Burns PHONE NO : 609 8061200 500 CHARLES EWING BLVD SE DECISION MADE: 09-SEP-16 EWING NJ 08628 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XP202 3M DEUTSCHLAND GMBH 510(k) NO: K161922(Third Party - Traditional) ATTN: RUEDIGER FRANKE PHONE NO : 49 8152 7001802 ESPE PLATZ SE DECISION MADE: 01-SEP-16 SEEFELD DE 82229 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Guidewire 0.6 Single Use FIGON GMBH 510(k) NO: K161940(Special) ATTN: Dirk Mucha PHONE NO : 49 3302 2012110 NEUENDORFSTR 23B SE DECISION MADE: 18-SEP-16 Hennigsdorf DE 16761 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector PERKINELMER, INC. 510(k) NO: K161942(Special) ATTN: Dawn Spooner PHONE NO : 781 6636071 940 WINTER STREET SE DECISION MADE: 01-SEP-16 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm) ENCORE MEDICAL, L.P. 510(k) NO: K161945(Special) ATTN: TEFFANY HUTTO PHONE NO : 512 8346255 9800 METRIC BLVD. SE DECISION MADE: 23-SEP-16 AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DoseCHECK Sun Nuclear Corporation 510(k) NO: K161946(Traditional) ATTN: Rene' Hardee PHONE NO : 321 2596862 2304 3275 Suntree Blvd. SE DECISION MADE: 16-SEP-16 Melbourne FL 32940 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Monoject Enteral Syringe with ENFit Connector COVIDIEN 510(k) NO: K161963(Traditional) ATTN: SONA MANICKAM PHONE NO : 508 2618147 15 HAMPSHIRE STREET SE DECISION MADE: 01-SEP-16 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector PerkinElmer, Inc. 510(k) NO: K161966(Special) ATTN: Dawn Spooner PHONE NO : 781 6636071 940 Winter Street SE DECISION MADE: 08-SEP-16 Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Interlocked Circular Small Field Collimators, Elekta Integrated AKTINA MEDICAL CORPORATION 510(k) NO: K161984(Traditional) ATTN: TONY SPACCAROTELLA PHONE NO : 845 2680101 18 360 NORTH ROUTE 9W SE DECISION MADE: 27-SEP-16 CONGERS NY 10920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K161992(Special) ATTN: JENNIFER SIEGEL PHONE NO : 609 2750500 311 ENTERPRISE DRIVE SE DECISION MADE: 22-SEP-16 PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Aerin Medical Stylus Aerin Medical, Inc. 510(k) NO: K161994(Special) ATTN: Scott Wolf PHONE NO : 650 4343247 690 W. Fremont Avenue, Unit 3 SE DECISION MADE: 22-SEP-16 Sunnyvale CA 94087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JiveX VISUS TECHNOLOGY TRANSFER GMBH 510(k) NO: K162008(Traditional) ATTN: AXEL SCHREIBER PHONE NO : 49 234 936930 Universitaetsstrasse 136 SE DECISION MADE: 16-SEP-16 Bochum DE 44799 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESCAPE Central Station V2 GE HEALTHCARE 510(k) NO: K162012(Special) ATTN: ROBERT CASARSA PHONE NO : 414 3623063 8200 WEST TOWER AVE. SE DECISION MADE: 15-SEP-16 MILWAUKEE WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Eusol-C AL.CHI.MI.A. S.r.l. 510(k) NO: K162013(Special) ATTN: Mauro Beccaro PHONE NO : 39 049 896207464 Viale Austria 14 SE DECISION MADE: 15-SEP-16 Ponte San Nicolo IT 35020 510(k) STATEMENT DEVICE: Affinity NT Oxygenator with Cortiva BioActive Surface MEDTRONIC, INC. 510(k) NO: K162016(Traditional) ATTN: RENEE CVEYKUS PHONE NO : 763 5053059 8200 CORAL SEA STREET NE (MVS83) SE DECISION MADE: 21-SEP-16 MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated COVIDIEN 510(k) NO: K162047(Special) ATTN: CELSO DURAN PHONE NO : 303 5306445 5920 LONGBOW DRIVE SE DECISION MADE: 15-SEP-16 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PhotonBlade Invuity Inc. 510(k) NO: K162053(Traditional) ATTN: John Kang PHONE NO : 415 6552160 444 De Haro Street SE DECISION MADE: 15-SEP-16 San Francisco CA 94107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZEE RETRIEVAL GENICON, INC 510(k) NO: K162059(Special) ATTN: KATLYN KACHMAN PHONE NO : 407 6574851 6869 STAPOINT COURT SUITE 114 SE DECISION MADE: 29-SEP-16 WINTER PARK FL 32792 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRILLIUM Oval Head Coil 32 HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K162079(Traditional) ATTN: DOUG THISTLETHWAITE PHONE NO : 330 4251313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 16-SEP-16 TWINSBURG OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TPH Spectra+ Universal Composite Restorative DENTSPLY SIRONA 510(k) NO: K162107(Traditional) ATTN: HELEN LEWIS PHONE NO : 717 4871332 221 W PHILADELPHIA ST, SUITE 60 SE DECISION MADE: 27-SEP-16 YORK PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORGRIP NG/NI Tube Retention System CORPAK MedSystems, Inc. a Division510(k) NO: K162110(Traditional) ATTN: Stephanie Wasielewski PHONE NO : 847 4033484 1001 Asbury Dr SE DECISION MADE: 15-SEP-16 Buffalo Grove IL 60089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAAS MRV Pie Medical Imaging BV 510(k) NO: K162112(Traditional) ATTN: Annemiek Bouts PHONE NO : 31 43 3281328 Philipsweg 1 SE DECISION MADE: 21-SEP-16 Maastricht NL 6227 AJ 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW) ArthoCare Corporation 510(k) NO: K162126(Traditional) ATTN: Ashley M. Johnson PHONE NO : 512 3585762 7000 West William Cannon Drive SE DECISION MADE: 29-SEP-16 Austin TX 78735 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Restore PACS XIAN WINGSPAN ELECTRONIC TECHNOLOG510(k) NO: K162141(Traditional) ATTN: Echo Chou PHONE NO : 86 159 29949205 Rm. A608, Pioneering Square, No. 4SE DECISION MADE: 02-SEP-16 Xi'an CN 710075 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FixxSure® X-Link INNOVASIS, INC. 510(k) NO: K162143(Traditional) ATTN: MARSHALL MCCARTY PHONE NO : 801 2612236 614 EAST 3900 SOUTH SE DECISION MADE: 23-SEP-16 SALT LAKE CITY UT 84107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBit Series Diagnostic Ultrasound System CHISON MEDICAL IMAGING CO., LTD. 510(k) NO: K162172(Traditional) ATTN: QIFEI LIU PHONE NO : 0086 510 85311707 NO.228, CHANGJIANG EAST ROAD, BLOCSE DECISION MADE: 14-SEP-16 WUXI CN 214142 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: dS FootAnkle I6CH 1.5T Coil Invivo Corporation 510(k) NO: K162177(Third Party - Traditional) ATTN: Ken Revennaugh PHONE NO : 352 3848590 3545 SW 47th Ave. SE DECISION MADE: 14-SEP-16 Gainesville FL 32608 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CareView 1500P X-ray Flat Panel Detectors CARERAY DIGITAL MEDICAL SYSTEM CO.510(k) NO: K162178(Special) ATTN: XU WEI PHONE NO : 86 512 86860288 109 B3-501, BIOBAY,218 XINGHU STREET SSE DECISION MADE: 01-SEP-16 SuZhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Edwards eSheath Introducer Set Edward Lifesciences 510(k) NO: K162184(Special) ATTN: Yi Gao PHONE NO : 949 2502295 1 Edward Way SE DECISION MADE: 02-SEP-16 Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Xario 100 Diagnostic Ultrasound System, V5.0 Toshiba Medical Systems Corporatio510(k) NO: K162187(Traditional) ATTN: Paul Biggins PHONE NO : 714 6697808 1385 Shimoishigami SE DECISION MADE: 30-SEP-16 Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) VR MEDICAL TECHNOLOGY 510(k) NO: K162188(Traditional) ATTN: LEE PAN PHONE NO : 86 512 57200050 90 GAOXIN ROAD, ZHOUZHANG SE DECISION MADE: 22-SEP-16 KUNSHAN CN 215325 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TSolution One Cup1 Surgical System THINK SURGICAL INC. 510(k) NO: K162195(Special) ATTN: IN K. MUN PHONE NO : 510 2492300 47320 MISSION FALLS COURT SE DECISION MADE: 14-SEP-16 FREMONT CA 94539 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUSON SC2000 Diagnostic Ultrasound System Siemens Medical Solutions Inc. Ult510(k) NO: K162221(Third Party - Special) ATTN: Kevon Kong PHONE NO : 650 9699112 685 East Middlefield Road SE DECISION MADE: 06-SEP-16 Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GENflex2 Total Knee System StelKast, Inc. 510(k) NO: K162222(Special) ATTN: Dave Stumpo PHONE NO : 724 7312208 200 Hidden Valley Road SE DECISION MADE: 07-SEP-16 McMurray PA 15317 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ArtPix Mobile EZ2GO CMT MEDICAL TECHNOLOGIES, LTD. 510(k) NO: K162224(Special) ATTN: LILIA SCHLOSBERG PHONE NO : 972 485 66220 HACARMEL ST. BLD 7/2, POB 111 INDUSE DECISION MADE: 22-SEP-16 YOQNEAM ILIT IL 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TorqVue Low Profile Delivery Catheter AGA MEDICAL CORPORATION (WHOLLY OW510(k) NO: K162228(Special) ATTN: Mary Johnson PHONE NO : 651 7562213 5050 NATHAN LANE SE DECISION MADE: 09-SEP-16 PLYMOUTH MN 55442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System Siemens Medical Solutions, Inc. 510(k) NO: K162243(Third Party - Traditional) ATTN: Shelly Pearce PHONE NO : 650 2790134 685 E MIDDLEFIELD RD SE DECISION MADE: 06-SEP-16 Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Cascadia Interbody System K2M, Inc. 510(k) NO: K162264(Special) ATTN: NANCY GIEZEN PHONE NO : 571 9192000 600 HOPE PARKWAY SE SE DECISION MADE: 21-SEP-16 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K162267(Special) ATTN: Zhai Pei PHONE NO : 0086 0755 81885604 MINDRAY BUILDING, KEJI 12TH RD S, SE DECISION MADE: 06-SEP-16 SHENZHEN CN 518057 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SonoSite iViz Ultrasound System FUJIFILM SONOSITE, INC. 510(k) NO: K162288(Third Party - Abbreviated) ATTN: Patricia Liau PHONE NO : 425 9516870 21919 30TH DRIVE SE SE DECISION MADE: 08-SEP-16 Bothell WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SomnoDent ALPHA SomnoMed Inc. 510(k) NO: K162306(Third Party - Abbreviated) ATTN: Kien Nguyen PHONE NO : 972 3773400 101 7460 Warren Pkwy Ste 190 SE DECISION MADE: 20-SEP-16 Frisco TX 75034 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OrthoPediatrics Locking Proximal Femur System Cortical Screws ORTHOPEDIATRICS, CORP. 510(k) NO: K162307(Special) ATTN: ADAM CARGILL PHONE NO : 574 2686379 2850 FRONTIER DRIVE SE DECISION MADE: 27-SEP-16 WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System Philips Healthcare 510(k) NO: K162329(Third Party - Traditional) ATTN: Maxs Newberry PHONE NO : 425 4828810 22100 Bothell Everett Highway SE DECISION MADE: 14-SEP-16 Bothell WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Nexcore GI Insufflator NEXCORE TECHNOLOGY, LLC 510(k) NO: K162332(Third Party - Traditional) ATTN: Julie Broderick PHONE NO : 781 254 5094 P.O. Box 903 SE DECISION MADE: 29-SEP-16 Winchester MA 01890 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: Symbia 6.5 SIEMENS MEDICAL SOLUTIONS, USA, IN510(k) NO: K162337(Special) ATTN: Cynthia Busch PHONE NO : 847 3047095 2501 N. BARRINGTON ROAD SE DECISION MADE: 08-SEP-16 Hoffman Estates IL 60192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Full Automatic (NIBP) Blood Pressure Monitor HEALTH & LIFE CO., LTD. 510(k) NO: K162338(Special) ATTN: SARAH SU PHONE NO : 886 282 271300 1201 9F, NO.186, JIAN YI ROAD SE DECISION MADE: 21-SEP-16 ZHONGHE DISTRICT, NEW TAIPEI CITY 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Scenium SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K162339(Special) ATTN: VERONICA PADHARIA PHONE NO : 630 8775761 810 INNOVATION DRIVE SE DECISION MADE: 21-SEP-16 KNOXVILLE TN 37932 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge NEOTRACT, INC. 510(k) NO: K162345(Special) ATTN: LOUIS-PIERRE MARCOUX PHONE NO : 925 2018861 4473 WILLOW ROAD, SUITE 100 SE DECISION MADE: 21-SEP-16 PLEASANTON CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Surefire Guiding Catheter Surefire Medical, Inc. 510(k) NO: K162359(Third Party - Special) ATTN: Lynne Aronson PHONE NO : 720 3059877 6272 W. 91st Avenue SE DECISION MADE: 21-SEP-16 Westminster CO 80031 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PowerGlide Pro Midline Catheter C.R. BARD, INC. 510(k) NO: K162377(Special) ATTN: JACOB LEE PHONE NO : 801 5225823 605 NORTH 5600 WEST SE DECISION MADE: 22-SEP-16 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TrailBlazer Angled Support Catheter Medtronic Vascular, Inc.(formerly 510(k) NO: K162384(Third Party - Traditional) ATTN: David Robertson PHONE NO : 763 3987000 3033 Campus Dr SE DECISION MADE: 22-SEP-16 Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: da Vinci Xi 12 – 8 mm Reducer Intuitive Surgical, Inc. 510(k) NO: K162411(Special) ATTN: Vishal Kanani PHONE NO : 408 5232035 1266 Kifer Road SE DECISION MADE: 21-SEP-16 Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IRIDEX Cyclo G6 Laser System, G-Probe Illuminate IRIDEX CORPORATION 510(k) NO: K162416(Special) ATTN: KATHY MAYNOR PHONE NO : 650 6058772 1212 TERRA BELLA AVENUE SE DECISION MADE: 29-SEP-16 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Acuson Freestyle Ultrasound System Siemens Medical Solutions, Inc. 510(k) NO: K162417(Third Party - Traditional) ATTN: Lawrence Engle PHONE NO : 610 8341220 102 5168 Campus Drive SE DECISION MADE: 28-SEP-16 Plymouth Meeting PA 19462 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: nva, nvp, and nvt NVISION BIOMEDICAL TECHNOLOGIES, L510(k) NO: K162426(Special) ATTN: Diana L. Langham PHONE NO : 210 5453713 1350 N LOOP 1604 E, SUITE 103 SE DECISION MADE: 29-SEP-16 SAN ANTONIO TX 78232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: mi-eye 2, mi-eye 2 monitor Trice Medical 510(k) NO: K162475(Special) ATTN: Tiffini Diage PHONE NO : 608 9898080 1000 Continental Dr. Suite 240 SE DECISION MADE: 16-SEP-16 King of Prussia PA 19406 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR EIZO CORPORATION 510(k) NO: K162497(Traditional) ATTN: Hiroaki Hashimoto PHONE NO : 81 76 2742468 153 SHIMOKASHIWANO SE DECISION MADE: 19-SEP-16 HAKUSAN JP 924-8566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 8MP Color LCD Monitor (C81W+) Shenzhen Beacon Display Technology510(k) NO: K162527(Traditional) ATTN: Fu Ailing PHONE NO : 86 0755 33985118 5150 12F, Block B1, Nanshan Zhiyuan, NoSE DECISION MADE: 30-SEP-16 Shenzhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD September 2016
TOTAL 510(k)s THIS PERIOD 257
TOTAL WITH SUMMARIES 250
TOTAL WITH STATEMENTS 7
DEVICE: BBX1, BBX2, BBX1MO, BBX1MC
GLOBALDENTAL, INC. 510(k) NO: The post FDA releases September 2016 510(k) clearances appeared first on MassDevice.