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
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The phaco handpiece is a surgical device used in phacoemulsification (laser eye surgery), a type of surgery involving the use of crystals to treat eye disease. This technology has advanced vision care for decades. The website Repair - ophthalmon.com offers some in-depth insights on ellips fx handpiece.
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