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  1. Device Approvals, Denials and Clearances

April 2017 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD April 2017


DEVICE: LED Curing Light
MONITEX INDUSTRIAL CO., LTD.      510(k) NO: K152192(Traditional)
ATTN: Shu-Lung   Wang             PHONE NO : 886 2 29993869 
6F, 70 SEC. 1 GUANG-FU ROAD SAN-CHSE DECISION MADE: 07-APR-17
NEW TAIPEI CITY  TW 241-58        510(k) STATEMENT
                                                    

DEVICE: K3
OSSTEM IMPLANT CO.,LTD.           510(k) NO: K152830(Traditional)
ATTN: BYEUNGHUN  KIM              PHONE NO : 82 70 43945157 
1ST FLOOR, B-DONG, 135 GASAN DIGITSE DECISION MADE: 20-APR-17
SEOUL   KR 153-759                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Howell Biliary Aspiration Needle
WILSON-COOK MEDICAL, INC.         510(k) NO: K153763(Traditional)
ATTN: Jennifer   McMahan          PHONE NO : 336 7440157 
4900 BETHANIA STATION ROAD        SE DECISION MADE: 06-APR-17
WINSTON SALEM NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VivaChek Ino Blood Glucose Monitoring System
VIVACHEK LABORATORIES, INC.       510(k) NO: K160179(Traditional)
ATTN: Julie  Zhou                 PHONE NO : 1 302 3398107 
913 N MARKET STREET SUITE 200     SE DECISION MADE: 21-APR-17
Wilmington DE  19081              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlowKeepers 
DK ELECTRONICS, LLC               510(k) NO: K160323(Traditional)
ATTN: AVERY  HUFF                 PHONE NO : 855 4945158 
413-B ELMWOOD AVE,                SE DECISION MADE: 06-APR-17
SHARON HILL PA  19079             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Apnea Risk Evaluation System (ARES), Model 620
Watermark Medical                 510(k) NO: K160499(Traditional)
ATTN: Frank  Katarow              PHONE NO : 877 7106999 
1641 Worthington Road, Suite 320  SE DECISION MADE: 24-APR-17
West Palm Beach FL  33409         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TEG 6s Hemostasis System
Haemonetics Corporation           510(k) NO: K160502(Special)
ATTN: Paige  Sweeney              PHONE NO : 781 3487295 
400 Wood Road                     SE DECISION MADE: 19-APR-17
Braintree MA  02184               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEDICAL DIODE LASER SYSTEMS
WUHAN GIGAA OPTRONICS TECHNOLOGY C510(k) NO: K160549(Traditional)
ATTN: NIE  XINXING                PHONE NO : 86 276 7848871 8045
5, 6/F, UNIT A, B, BUILDING B8, HISE DECISION MADE: 07-APR-17
 EAST LAKE DEVELOPMENT ZONE, WUHAN510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ET US SS Prosthetic system
OSSTEM IMPLANT CO., LTD.          510(k) NO: K160670(Traditional)
ATTN: HEE  KWON                   PHONE NO : 82 518 502575 
#507-8 GEOJE3-DONG YEONJE-GU      SE DECISION MADE: 25-APR-17
Busan  KR 611-804                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VisioFocus Mini, VisioFocus Smart
TECNIMED S.R.L.                   510(k) NO: K160680(Traditional)
ATTN: Cinzia  Bellifemine         PHONE NO : 39 033 2402350 
12, P.LE COCCHI                   SE DECISION MADE: 19-APR-17
Vedano Olona  IT 21040            510(k) STATEMENT
                                                    

DEVICE: Disposable Endotracheal tube, sterile, AccuCuff
TIANJIN MEDIS MEDICAL DEVICE CO., 510(k) NO: K160694(Traditional)
ATTN: ZHENCHUANG  YANG            PHONE NO : 86 022 83988488 
10-A TIANZHI INDUSTRIAL CENTER, NOSE DECISION MADE: 07-APR-17
TIANJIN CITY  CN 300385           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Instrument kits
ANTHOGYR                          510(k) NO: K160730(Traditional)
ATTN: Therese  CANDAU             PHONE NO : 330 4 50580237 
2237 avenue Andre Lasquin         SE DECISION MADE: 27-APR-17
SALLANCHES  FR 74700              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Finapres Nova Noninvasive Hemodynamic Monitor
FINAPRES MEDICAL SYSTEMS BV       510(k) NO: K160967(Traditional)
ATTN: IR. IRIS VAN UITERT         PHONE NO : 31 206 090974 
HOGEHILWEG 8                      SE DECISION MADE: 18-APR-17
AMSTERDAM  NL 1101 CC             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nova Max Uric Acid Monitoring System
NOVA BIOMEDICAL CORPORATION       510(k) NO: K160990(Traditional)
ATTN: ELIZA  WANG                 PHONE NO : 781 6473700 743
200 PROSPECT STREET               SE DECISION MADE: 11-APR-17
WALTHAM MA  02454                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HIGH V+
Teknimed, SAS                     510(k) NO: K161114(Traditional)
ATTN: J.D.  Webb                  PHONE NO : 512 3880199 
11, Rue d'Apollo                  SE DECISION MADE: 12-APR-17
L'Union  FR 31240                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intelli-Ox
AIR LIQUIDE HEALTHCARE AMERICA COR510(k) NO: K161179(Traditional)
ATTN: Steve  Miller               PHONE NO : 713 8962280 
12800 West Little York Road       SE DECISION MADE: 13-APR-17
HOUSTON  TX  77041-2280           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NILE Proximal Fixation Spinal System
K2M, INC.                         510(k) NO: K161332(Traditional)
ATTN: NANCY  GIEZEN               PHONE NO : 571 9192000 
600 HOPE PARKWAY SE               SE DECISION MADE: 05-APR-17
LEESBURG VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIFESYS PACS
LIFETRACK MEDICAL SYSTEMS, INC.   510(k) NO: K161341(Traditional)
ATTN: ERIC  SCHULZE               PHONE NO : 63 2 8029980 
1007 ONE WORLD PLACE, 32ND STREET,SE DECISION MADE: 05-APR-17
TAGUIG CITY  PH 1634              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ESTELITE BULK FILL Flow
TOKUYAMA DENTAL CORPORATION       510(k) NO: K161353(Traditional)
ATTN: KEITH A. BARRITT            PHONE NO : 011 813 38352261 
38-9 TAITOU 1-CHOME, TAITOU-KU    SE DECISION MADE: 03-APR-17
TOKYO  JP 110-0016                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HAMILTON-C3
HAMILTON MEDICAL AG               510(k) NO: K161450(Traditional)
ATTN: Katrin  Vogt                PHONE NO : 41 58610 1479 
VIA CRUSCH 8                      SE DECISION MADE: 27-APR-17
BONADUZ  CH 7402                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters
AngioDynamics, Inc.               510(k) NO: K161596(Traditional)
ATTN: Teri  Juckett               PHONE NO : 518 7951142 
603 Queensbury Ave                SE DECISION MADE: 28-APR-17
Queensbury  NY  12804             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UNO Negative Pressure Wound Therapy System
GENADYNE BIOTECHNOLOGIES, INC.    510(k) NO: K161599(Traditional)
ATTN: Chien  Ming  GOH            PHONE NO : 516 4878787 
16 MIDLAND AVE                    SE DECISION MADE: 06-APR-17
HICKSVILLE NY  11801              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arm automatic blood pressure monitor
SHENZHEN PUMP MEDICAL SYSTEM CO., 510(k) NO: K161712(Special)
ATTN: XIE  QIONGYU                PHONE NO : 086 0755 26710795 
2/F WEST, M-7 SINOSTEEL BUILDING, SE DECISION MADE: 05-APR-17
NANSHAN DISTRICT, SHENZHEN  CN 518510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)
RadioMed Corporation              510(k) NO: K161724(Traditional)
ATTN: Leah  Easley                PHONE NO : 901 4327202 
3150 Stage Post Drive Suite 110   SE DECISION MADE: 28-APR-17
Bartlett TN  38133                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GMK UNI
MEDACTA INTERNATIONAL SA          510(k) NO: K161741(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 916 966060 
STRADA REGINA                     SE DECISION MADE: 14-APR-17
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Etgar Dental Implant System
ETGAR MEDICAL INSTRUMENTS, LTD    510(k) NO: K161743(Traditional)
ATTN: Yehudit  Pe’er              PHONE NO : 972 498 20810 
NORTH INDUSTRIAL AREA             SE DECISION MADE: 14-APR-17
Nahariyah  IL 22102               510(k) STATEMENT
                                                    

DEVICE: CENTURION Vision System (Active SentryTM)
Alcon Research, Ltd.              510(k) NO: K161794(Traditional)
ATTN: Paul  Swift                 PHONE NO : 817 6152952 
6201 SOUTH FREEWAY DR.            SE DECISION MADE: 14-APR-17
FORT WORTH TX  76134-2099         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Huvitz Imaging System
HUVITZ CO., LTD.                  510(k) NO: K161829(Traditional)
ATTN: KIM  EUN-JO                 PHONE NO : 82 31 4289142 
GONGDAN-RO                        SE DECISION MADE: 06-APR-17
GUNPO-SI  KR 435-862              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Salvin Tenting Screw System
Salvin Dental Specialties         510(k) NO: K161857(Traditional)
ATTN: Jennifer  Singer            PHONE NO : 704 4425400 
3450 Latrobe Drive                SE DECISION MADE: 28-APR-17
Charlotte NC  28211               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ortho System
3Shape A/S                        510(k) NO: K161884(Traditional)
ATTN: Hanne  Nielsen              PHONE NO : 45 702 72620 
Holmens Kanal 7                   SE DECISION MADE: 19-APR-17
Copenhagen  DK 1060               510(k) STATEMENT
                                                    

DEVICE: Cardinal Health Sterilization Wrap
CARDINAL HEALTH 200, LLC          510(k) NO: K161910(Traditional)
ATTN: MEGAN  MIDDAUGH             PHONE NO : 847 8876812 
1500 WAUKEGAN ROAD                SE DECISION MADE: 20-APR-17
WAUKEGAN IL  60085                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UltraScan 650
CyberLogic, Inc.                  510(k) NO: K161919(Traditional)
ATTN: Jonathan J. Kaufman         PHONE NO : 212 2601351 
611 Boradway, Suite 707           SE DECISION MADE: 05-APR-17
New York NY  10012                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C-Reactive Protein Kit for use on SPAPLUS
THE BINDING SITE GROUP            510(k) NO: K161982(Traditional)
ATTN: KIRSTY  SAMUELS             PHONE NO : 44 012 14569500 
8 CALTHORPE ROAD, EDGBASTON       SE DECISION MADE: 05-APR-17
BIRMINGHAM  GB B15 1QT            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ross Ru Wound Dressing Gel
BIOTD, S.A.                       510(k) NO: K162017(Traditional)
ATTN: Lawrence  Pratt             PHONE NO : 506 883 74323 
EDIFICIO 26 CONDOMINIO INDUSTRIAL SE DECISION MADE: 20-APR-17
Heredia  CR                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MINNE TIES MMF Suture System
SUMMIT MEDICAL, INC.              510(k) NO: K162046(Traditional)
ATTN: Nicole  Dove                PHONE NO : 651 7893939 
815 NORTHWEST PKWY, STE 100       SE DECISION MADE: 11-APR-17
ST. PAUL MN  55121                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Steri-Cassette and Steri-Cage Sterilization Packaging System
Sybron Dental Specialties         510(k) NO: K162063(Traditional)
ATTN: Jennifer  Dzidrums          PHONE NO : 909 9625666 
1717 W. Collins Ave.              SE DECISION MADE: 21-APR-17
Orange CA  92867                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VX130 Ophthalmic Diagnostic Device
LUNEAU SAS                        510(k) NO: K162067(Traditional)
ATTN: ISABELLE  DURAND            PHONE NO : 33 2 37252525 
1 AVE DE MALAGUET                 SE DECISION MADE: 24-APR-17
PRUNAY-LE-GILLON  FR 28360        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARROW Anatomical Porous glenoid
Fournitures Hospitalieres Industri510(k) NO: K162068(Traditional)
ATTN: Patricia  Donnard           PHONE NO : 33 2 98556895 
ZI de Kernevez – 6 rue Nobel      SE DECISION MADE: 10-APR-17
Quimper  FR 29000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NovoGro
OsteoNovus, Inc.                  510(k) NO: K162087(Traditional)
ATTN: Brian M. Schlossberg        PHONE NO : 1 617 7178867 
1510 North Westwood Avenue, Suite SE DECISION MADE: 18-APR-17
Toledo OH  43606                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C-Flex Ureteral Stent Set
COOK INCORPORATED                 510(k) NO: K162104(Traditional)
ATTN: MINJIN  CHOI                PHONE NO : 812 3392235 104901
750 DANIELS WAY                   SE DECISION MADE: 24-APR-17
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pressio 2 ICP Monitoring System
SOPHYSA, SA                       510(k) NO: K162108(Traditional)
ATTN: Jean-Christophe  Audras     PHONE NO : 33 1 69353500 
5, rue Guy Moquet                 SE DECISION MADE: 17-APR-17
ORSAY, Cedex  FR 91400            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Scope-Assist Flushing Sink
Custom Ultrasonics Inc.           510(k) NO: K162120(Traditional)
ATTN: Elizabeth  Lazaro           PHONE NO : 215 3641477 
144 Railroad Drive                SE DECISION MADE: 28-APR-17
Ivyland PA  18974                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Accessory Irrigation Adapter
WILSON-COOK MEDICAL, INC.         510(k) NO: K162142(Traditional)
ATTN: THERESA DE PRAT             PHONE NO : 336 7440157 6518
4900 BETHANIA STATION RD          SE DECISION MADE: 27-APR-17
WINSTON-SALEM NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PENTAX Medical ENT Video Imaging System
PENTAX OF AMERICA, INC.           510(k) NO: K162151(Traditional)
ATTN: Krishna  Govindarajan       PHONE NO : 800 4315880 
3 PARAGON DRIVE                   SE DECISION MADE: 20-APR-17
MONTVALE NJ  07645-1782           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pantheon Medical Balanced Plating System
PANTHEON MEDICAL                  510(k) NO: K162154(Traditional)
ATTN: TRAVID  BIRD                PHONE NO : 214 9540406 
1505 FEDERAL ST, #300             SE DECISION MADE: 24-APR-17
DALLAS TX  75201                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing
VR Medical Technologies, LLC      510(k) NO: K162159(Traditional)
ATTN: Lee  Pan                    PHONE NO : 626 2275727 
90 Gaoxin Rd.                     SE DECISION MADE: 28-APR-17
Kunshan  CN 215325                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Randox RX Daytona Plus Magnesium (MG)
RANDOX LABORATORIES LTD           510(k) NO: K162200(Traditional)
ATTN: PAULINE 0 ARMSTRONG         PHONE NO : 44 0 2894422413 
55 DIAMOND ROAD                   SE DECISION MADE: 28-APR-17
CRUMLIN  GB BT29 4QY              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: POGO Automatic Blood Glucose Monitoring System
Intuity Medical, Inc.             510(k) NO: K162203(Traditional)
ATTN: Robb  Hesley                PHONE NO : 408 5301700 275
526 Almanor Avenue                SE DECISION MADE: 06-APR-17
Sunnyvale CA  94085               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zavation IBF
Zavation, LLC                     510(k) NO: K162206(Traditional)
ATTN: Lawrence  Walker            PHONE NO : 601 9191119 
220 Lakeland Pkwy                 SE DECISION MADE: 04-APR-17
Flowood MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ax Stand-Alone ALIF System
INNOVASIS, INC.                   510(k) NO: K162236(Traditional)
ATTN: Marshall  McCarty           PHONE NO : 801 2612236 
614 EAST 3900 SOUTH               SE DECISION MADE: 20-APR-17
SALT LAKE CITY UT  84107          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XO1 Knee Balancing System
XPANDORTHO, INC.                  510(k) NO: K162237(Traditional)
ATTN: REBECCA K PINE              PHONE NO : 760 8095178 
2223 AVENIDA DE LA PLAYA SUITE 203SE DECISION MADE: 25-APR-17
LA JOLLA CA  92037-3218           510(k) STATEMENT
                                                    

DEVICE: TITAN 3-D™ Wedge System
PARAGON 28                        510(k) NO: K162241(Traditional)
ATTN: Frank S. Bono               PHONE NO : 888 7281888 
4B INVERNESS CT.E., STE 280       SE DECISION MADE: 03-APR-17
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Self Sealing Sterilization Pouches
Tianchang Jiarui Packaging Materia510(k) NO: K162258(Traditional)
ATTN: Zhang  Ruiqing              PHONE NO : 86 550 7981778 
Yeshan Industria Zone             SE DECISION MADE: 28-APR-17
TianChang  CN 239300              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pro-Lock CT Safety Infusion Set
MEDCOMP (MEDICAL COMPONENTS, INC.)510(k) NO: K162271(Traditional)
ATTN: COURTNEY  NIX               PHONE NO : 215 2564201 
1499 DELP DRIVE                   SE DECISION MADE: 26-APR-17
HARLEYSVILLE PA  19438            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Randox RX Daytona Plus Alkaline Phosphatase (ALP)
RANDOX LABORATORIES LIMITED       510(k) NO: K162275(Traditional)
ATTN: Pauline  Armstrong          PHONE NO : 44 0 2894422413 
55 DIAMOND ROAD                   SE DECISION MADE: 21-APR-17
CRUMLIN, COUNTY ANTRIM  GB BT29 4Q510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Synapse 3D Perfusion Analysis
FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K162287(Traditional)
ATTN: Jyh-Shyan  Lin              PHONE NO : 301 2511092 
419 WEST AVENUE                   SE DECISION MADE: 06-APR-17
Stamford CT  06902                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS
BRIGHTWAY HOLDINGS SDN BHD.       510(k) NO: K162294(Traditional)
ATTN: G.  BASKARAN                PHONE NO : 603 33431007 
LOT 1559, JALAN ISTIMEWA, BATU BELSE DECISION MADE: 21-APR-17
KLANG, SELANGOR  MY 42100         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OmniPod Insulin Management System
INSULET CORPORATION               510(k) NO: K162296(Traditional)
ATTN: MATTHEW  KING               PHONE NO : 978 6007427 
600 TECHNOLOGY PARK DRIVE SUITE 20SE DECISION MADE: 18-APR-17
BILLERICA MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
Diazyme Laboratories              510(k) NO: K162297(Traditional)
ATTN: Abhijit  Datta              PHONE NO : 858 4554762 
12889 Gregg Court                 SE DECISION MADE: 18-APR-17
Poway CA  92130                   510(k) STATEMENT
                                                    

DEVICE: BabyDance Fertility Lubricant
Fairhaven Health, LLC             510(k) NO: K162319(Traditional)
ATTN: Suzanne  Munson             PHONE NO : 360 5437888 
1410 11th St                      SE DECISION MADE: 28-APR-17
Bellingham WA  98225              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: U.S. Laser Worx Patriot 1 family of lasers
U.S. Laser Worx                   510(k) NO: K162334(Traditional)
ATTN: Frank  Ford                 PHONE NO : 210 8857679 
13423 Blanco Rd #162              SE DECISION MADE: 27-APR-17
San Antonio TX  78216             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MICATM Screw System
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K162353(Traditional)
ATTN: TARA  CONRAD                PHONE NO : 901 8674367 
1023 CHERRY RD                    SE DECISION MADE: 13-APR-17
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sniper Staple System
TRILLIANT SURGICAL LTD            510(k) NO: K162354(Traditional)
ATTN: Jon  Olson                  PHONE NO : 713 3886055 
6721 Portwest Dr. Suite 160       SE DECISION MADE: 20-APR-17
Houston TX  77024                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Soft Plug Extended Duration 180 Canalicular Plug
OASIS MEDICAL, INC.               510(k) NO: K162361(Traditional)
ATTN: JAMES  CHRISTENSEN          PHONE NO : 909 3055400 
514 S. VERMONT AVENUE             SE DECISION MADE: 17-APR-17
GLENDORA CA  91741                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smart Dongle Blood Glucose Monitoring System
TaiDoc Technology Corporation     510(k) NO: K162382(Traditional)
ATTN: Paul  Liu                   PHONE NO : 886 2 66258188 6134
B1-7F, No. 127, Wugong 2nd Rd., WuSE DECISION MADE: 14-APR-17
New Taipei City  TW 24888         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RAPIDEC CARBA NP
BIOMERIEUX SA                     510(k) NO: K162385(Traditional)
ATTN: ASA  KARLSSON               PHONE NO : 33 06 48616849 
5 RUE DES AQUEDUCS                SE DECISION MADE: 27-APR-17
CRAPONNE  FR 69290                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sofia Influenza A+B FIA on Sofia 2
Quidel Corporation                510(k) NO: K162438(Traditional)
ATTN: Jennifer S. Rial            PHONE NO : 858 5527910 
12544 High Bluff Drive, Suite 200 SE DECISION MADE: 14-APR-17
San Diego CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PowerPICC Provena Catheters with SOLO Valve Technology
C.R. BARD, INC                    510(k) NO: K162441(Traditional)
ATTN: BRYAN  STONE                PHONE NO : 801 5225876 
605 NORTH 5600 WEST               SE DECISION MADE: 24-APR-17
SALT LAKE CITY UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner
PENTAX of America, Inc.           510(k) NO: K162447(Traditional)
ATTN: Krishna  Govindarajan       PHONE NO : 800 4315880 
3 Paragon Drive                   SE DECISION MADE: 13-APR-17
Montvale NJ  07645-1782           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts
WAVI, CO                          510(k) NO: K162460(Traditional)
ATTN: ALEXIS  VERACRUZ            PHONE NO : 804 9092389 
3535 S IRVING ST.                 SE DECISION MADE: 28-APR-17
ENGLEWOOD CO  80110               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optiflux dialyzer
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K162488(Traditional)
ATTN: DENISE  OPPERMANN           PHONE NO : 781 6994479 
920 WINTER ST.                    SE DECISION MADE: 06-APR-17
WALTHAM MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13
JKH Health Co., Ltd.              510(k) NO: K162517(Traditional)
ATTN: Pu  Jiang                   PHONE NO : 86 755 27926589 
4-5F, Building 12, Hengmingzhu IndSE DECISION MADE: 14-APR-17
Shenzhen  CN 518104               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OsteoMed PINNACLE Driver
OSTEOMED                          510(k) NO: K162544(Traditional)
ATTN: KATHRYN A. JAYNE            PHONE NO : 972 6774766 
3885 ARAPAHO ROAD                 SE DECISION MADE: 04-APR-17
ADDISON TX  75001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ExactechGPS Total Shoulder Application, Equinoxe Planning Software
Blue Ortho                        510(k) NO: K162567(Traditional)
ATTN: Anthony  Boyer              PHONE NO : 33 47 6549546 
5 Avenue du Grand Sablon          SE DECISION MADE: 05-APR-17
La Tronche  FR 38700              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BeneVision Central Monitoring System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K162607(Traditional)
ATTN: Yanhong  Bai                PHONE NO : 86 755 81888998 
Mindray Building, Keji 12th Road SSE DECISION MADE: 20-APR-17
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NobleStitch EL
NOBLES MEDICAL TECHNOLOGIES II, IN510(k) NO: K162617(Abbreviated)
ATTN: FAYE  DUNN                  PHONE NO : 714 4276348 268
17074 NEWHOPE ST.                 SE DECISION MADE: 06-APR-17
FOUNTAIN VALLEY CA  92708         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair
Invacare Corporation              510(k) NO: K162621(Traditional)
ATTN: Elijah N. Wreh              PHONE NO : 440 3296840 
One Invacare Way                  SE DECISION MADE: 17-APR-17
Elyria OH  44035                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Marco Ultra M3, Marco Ultra M4
TAKAGI SEIKO CO.LTD.              510(k) NO: K162636(Traditional)
ATTN: HAGIWARA  TORU              PHONE NO : 81 269 224512 
330-2 IWAHUNE, NAKANO-SHI, NAGANO-SE DECISION MADE: 14-APR-17
NAKANO  JP 383-8585               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
ALERE SCARBOROUGH, INC.           510(k) NO: K162642(Traditional)
ATTN: SARA  HALLOWELL             PHONE NO : 207 7305786 
10 SOUTHGATE ROAD                 SE DECISION MADE: 10-APR-17
SCARBOROUGH ME  04074             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StealthConnect Remote Viewing, Planning and Collaboration System
MEDTRONIC NAVIGATION, INC.        510(k) NO: K162655(Traditional)
ATTN: MONICA R. MONTANEZ          PHONE NO : 720 8902149 
826 COAL CREEK CIRCLE             SE DECISION MADE: 21-APR-17
LOUISVILLE CO  80027              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SavDenTM MTA Root Canal Filling Materials
tYDS Biotech Incorporation        510(k) NO: K162661(Traditional)
ATTN: Liang-Yu  Chang             PHONE NO : 886 3 6589590 
Rm. 7, 2F., No.229, Fuxing 2nd Rd SE DECISION MADE: 25-APR-17
Zhubei City, Hsinchu County  TW 30510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IOB Temperature Management System
IOB MEDICAL INC                   510(k) NO: K162679(Traditional)
ATTN: JIULIN  XIA                 PHONE NO : 301 2500831 
504E DIAMOND AVE., SUITE I        SE DECISION MADE: 28-APR-17
GAITHERSBURG MD  20877            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HyperSense
GE MEDICAL SYSTEMS, LLC           510(k) NO: K162722(Traditional)
ATTN: GLEN  SABIN                 PHONE NO : 262 8944968 
3200 GRANDVIEW BLVD               SE DECISION MADE: 20-APR-17
WAUKESHA WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exactech® Alteon® HA Femoral Stem
EXACTECH INC                      510(k) NO: K162732(Traditional)
ATTN: Thomas  McNamara            PHONE NO : 352 3771140 
2320 NW 66TH COURT                SE DECISION MADE: 26-APR-17
GAINESVILLE FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MindMotionPRO
MindMaze SA                       510(k) NO: K162748(Traditional)
ATTN: SYLVAIN  BOURRIQUET         PHONE NO : 41 21 5520801 
Chemin de Roseneck 5              SE DECISION MADE: 24-APR-17
Lausanne  CH CH-1006              510(k) STATEMENT
                                                    

DEVICE: iHelmet Hair Growth System
Slinph Technologies Co., LTD      510(k) NO: K162782(Traditional)
ATTN: Zou  Jian                   PHONE NO : 86 158 15568501 
Room 211, Building B, 1970 CulturaSE DECISION MADE: 04-APR-17
Shenzhen  CN 518107               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Velox Nebulizer System
PARI Respiratory Equipment, Inc.  510(k) NO: K162785(Traditional)
ATTN: Michael  Judge              PHONE NO : 804 2537274 269
2412 PARI Way                     SE DECISION MADE: 14-APR-17
Midlothian VA  23112              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cliniview
Palodex Group Oy                  510(k) NO: K162799(Traditional)
ATTN: Jouni  Karkinen             PHONE NO : 358 10 2702000 
Nahkelantie 160                   SE DECISION MADE: 25-APR-17
Tuusula  FI FI-04300              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Philips iCT CT System
Philips Medical Systems (Cleveland510(k) NO: K162838(Traditional)
ATTN: Christine  Anderson         PHONE NO : 440 4837732 
595 Miner Rd                      SE DECISION MADE: 07-APR-17
Cleveland OH  44143               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VOCSN Unified Respiratory System
VENTEC LIFE SYSTEMS, INC          510(k) NO: K162877(Traditional)
ATTN: Joseph  Cipollone           PHONE NO : 909 2133691 
19021 120TH AVE NE SUITE 101      SE DECISION MADE: 07-APR-17
BOTHELL WA  98011                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Complete Control System
COAPT, LLC                        510(k) NO: K162891(Traditional)
ATTN: Blair  Lock                 PHONE NO : 844 2627800 
222 WEST ONTARIO STREET UNIT#300  SE DECISION MADE: 14-APR-17
Chicago IL  60654                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Penumbra 3D Revascularization Device
Penumbra, Inc.                    510(k) NO: K162901(Traditional)
ATTN: Michaela  Mahl              PHONE NO : 510 7483288 
One Penumbra Place                SE DECISION MADE: 20-APR-17
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AcQGuide Steerable Sheath
ACUTUS MEDICAL, INC.              510(k) NO: K162925(Traditional)
ATTN: Brenda  Clay                PHONE NO : 442 2326080 
2210 FARADAY AVE SUITE 100        SE DECISION MADE: 06-APR-17
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRECICE UNYTE CoCr System
NuVasive Specialized Orthopedics, 510(k) NO: K162927(Traditional)
ATTN: Cora  Sim                   PHONE NO : 949 5446478 
101 Enterprise, Suite 100         SE DECISION MADE: 06-APR-17
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aero Chrome* Select Breathable Performance Surgical Gowns
Halyard Health, Inc.              510(k) NO: K162930(Traditional)
ATTN: David M. Lee                PHONE NO : 470 4485182 
5405 Windward Parkway             SE DECISION MADE: 21-APR-17
Alpharetta GA  30004              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERIFY ASSERT STEAM Process Challenge Device
STERIS Corporation                510(k) NO: K162945(Traditional)
ATTN: Ganga  Kolli                PHONE NO : 440 3586261 
5976 Heisley Rd                   SE DECISION MADE: 28-APR-17
Mentor OH  44060                  510(k) STATEMENT
                                                    

DEVICE: VORTRAN GO2VENT
VORTRAN MEDICAL TECHNOLOGY 1, INC.510(k) NO: K162968(Traditional)
ATTN: James  Lee                  PHONE NO : 916 6488460 15
21 GOLDENLAND COURT, #100         SE DECISION MADE: 10-APR-17
SACRAMENTO CA  95834              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PowerFlow Apheresis I.V. Port
C.R. BARD, INC.                   510(k) NO: K163001(Traditional)
ATTN: Christoph  Wagner von Hoff  PHONE NO : 480 6382925 
605 NORTH 5600 WEST               SE DECISION MADE: 17-APR-17
SALT LAKE CITY UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HAAG-STREIT FUNDUS MODULE 300
OPTOMED OY                        510(k) NO: K163021(Traditional)
ATTN: Jyri  Leskela               PHONE NO : 358 20 7413380 
Yrttipellontie 1                  SE DECISION MADE: 11-APR-17
Oulu  FI 90230                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Segment CMR
MEDVISO AB                        510(k) NO: K163076(Traditional)
ATTN: Einar  Heiberg              PHONE NO : 46 70 2788938 
GRIFFELVAGEN 3                    SE DECISION MADE: 05-APR-17
LUND  SE SE-22467                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TSIII BA Fixture
OSSTEM IMPLANT Co., Ltd.          510(k) NO: K163088(Traditional)
ATTN: Hee  Kwon                   PHONE NO : 82 51 8502575 
66-16, Bansong-ro 513beon-gil, haeSE DECISION MADE: 21-APR-17
Busan  KR 612-070                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set
MICROGENICS CORPORATION           510(k) NO: K163101(Traditional)
ATTN: MINOTI  PATEL               PHONE NO : 510 9795000 
46500 KATO ROAD                   SE DECISION MADE: 06-APR-17
FREMONT CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators
FIRSTKIND LIMITED                 510(k) NO: K163125(Traditional)
ATTN: NEIL  BUCKLEY               PHONE NO : 44 01494 572040 
HAWK HOUSE PEREGRINE BUSINESS PARKSE DECISION MADE: 10-APR-17
HIGH WYCOMBE  GB HP13 7DL         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)
GKE-GMBH                          510(k) NO: K163144(Traditional)
ATTN: Ulrich  Kaiser              PHONE NO : 49 612 694320 
AUF DER LIND 10                   SE DECISION MADE: 07-APR-17
Waldems  DE 65529                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VisualEyes
Interacoustics A/S                510(k) NO: K163149(Traditional)
ATTN: Erik  Nielsen               PHONE NO : 45 63 713555 
Audiometer Alle 1                 SE DECISION MADE: 26-APR-17
Middelfart  DK 5500               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Single-use Infusion Set
JiangXi HongDa Medical Equipment G510(k) NO: K163160(Traditional)
ATTN: Xiaohua  Yang               PHONE NO : 86 791 85628918 
No. 39 South Shengli Road, JinxianSE DECISION MADE: 20-APR-17
Nanchang  CN 331700               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CeraClean
Bisco, Inc.                       510(k) NO: K163171(Traditional)
ATTN: Ryan  Hobson                PHONE NO : 847 5346143 
1100 West Irving Park Road        SE DECISION MADE: 14-APR-17
Schaumburg IL  60193              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Comfort EC710
ALLTECH MEDICAL SYSTEMS AMERICA, I510(k) NO: K163192(Traditional)
ATTN: MICHAELEEN  DOM             PHONE NO : 440 4242240 
28900 FOUNTAIN PARKWAY SUITE A    SE DECISION MADE: 10-APR-17
SOLON OH  44139                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Atellica CH Phencyclidine (Pcp)
Siemens Healthcare Diagnostics, In510(k) NO: K163220(Traditional)
ATTN: Laura J. Duggan             PHONE NO : 302 6317654 
500 GBC Drive, PO Box 6101 MS 514 SE DECISION MADE: 06-APR-17
Newark DE  19711                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mazor X
Mazor Robotics Ltd.               510(k) NO: K163221(Traditional)
ATTN: Ayelet  Matia               PHONE NO : 972 4 6187100 
7 HaEshel St.                     SE DECISION MADE: 04-APR-17
Caesarea  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter
MIVI NEUROSCIENCE, INC            510(k) NO: K163233(Traditional)
ATTN: Randy  LaBounty             PHONE NO : 952 9443834 
6545 City West Parkway            SE DECISION MADE: 06-APR-17
Eden Prairie MN  55344            510(k) STATEMENT
                                                    

DEVICE: HEM-9210T
Omron Healthcare, Inc.            510(k) NO: K163235(Traditional)
ATTN: Renee  Thornborough         PHONE NO : 847 2475626 
1925 West Field Court             SE DECISION MADE: 20-APR-17
Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Leva Anterior Expandable Spacer System
SPINE WAVE, INC.                  510(k) NO: K163246(Traditional)
ATTN: AMY  NOCCIOLI               PHONE NO : 203 9449494 
3 ENTERPRISE DRIVE, SUITE 210     SE DECISION MADE: 06-APR-17
SHELTON CT  06484                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor
Caretaker Medical, LLC            510(k) NO: K163255(Traditional)
ATTN: Jeff  Pompeo                PHONE NO : 434 4091945 
3042 Berkmar Drive, Suite A       SE DECISION MADE: 21-APR-17
Charlottesville VA  22901         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dual Mode Infrared Thermometer
Intelliworks LLC                  510(k) NO: K163256(Traditional)
ATTN: Dr. Jessica  Leonardi       PHONE NO : 858 888 9781
4910 Wright Road, Ste 120         SE DECISION MADE: 06-APR-17
Stafford TX  77477                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kepler II
Orbbo Surgical, LLC               510(k) NO: K163265(Traditional)
ATTN: Eric  Garofano              PHONE NO : 800 942 1880
555 W. 5th Street, 35th Floor     SE DECISION MADE: 07-APR-17
Los Angeles CA  90013             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device
TITAN SPINE, LLC                  510(k) NO: K163269(Traditional)
ATTN: JANE  RODD                  PHONE NO : 262 2427801 
6140 W. EXECUTIVE DR STE A        SE DECISION MADE: 13-APR-17
MEQUON WI  53092                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: i-Stat Alinity System with i-Stat Glucose test
Abbott Point of Care, Inc.        510(k) NO: K163271(Traditional)
ATTN: Maria L Figueroa            PHONE NO : 609 454 9271
400 College Road East             SE DECISION MADE: 10-APR-17
Princeton NJ  08540               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument
Aggredyne, Inc.                   510(k) NO: K163274(Special)
ATTN: Philip C. Speros            PHONE NO : 713 6365996 
10530 Rockley Road, Suite 150     SE DECISION MADE: 05-APR-17
Houston TX  77099                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OsteoMed ExtremiFix Mid and Large Screw System
OsteoMed LLC                      510(k) NO: K163303(Traditional)
ATTN: Ellen  Hong                 PHONE NO : 972 6774795 
 3885 Arapaho Rd                  SE DECISION MADE: 04-APR-17
Addison TX  75001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72
PULSADERM LLC                     510(k) NO: K163329(Traditional)
ATTN: Gloria  Avendano            PHONE NO : 
12801 COMMONWEALTH DR. UNITS 2-6  SE DECISION MADE: 14-APR-17
Fort Myers FL  33913              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Apex Revision Knee System
OMNIlife science                  510(k) NO: K163332(Special)
ATTN: Christina  Rovaldi          PHONE NO : 774 226 1857
480 Paramount Drive               SE DECISION MADE: 26-APR-17
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
Ad-Tech Medical Instrument Corpora510(k) NO: K163355(Traditional)
ATTN: Lisa  Theama                PHONE NO : 262 6341555 
1901 William Street               SE DECISION MADE: 12-APR-17
Racine WI  53404                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Introcan Safety 3 Closed IV Catheter
B.BRAUN MELSUNGEN AG              510(k) NO: K163358(Special)
ATTN: ULRICH  JEDELHAUSER         PHONE NO : 49 566 1711870 
1 CARL BRAUN STR.                 SE DECISION MADE: 28-APR-17
MELSUNGEN  DE 34212               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANTHEM™ Fracture System
Globus Medical Inc.               510(k) NO: K163361(Traditional)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 1670
2560 General Armistead Ave.       SE DECISION MADE: 07-APR-17
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SurgTech Thoracolumbosacral (TLS) Posterior Fixation System
SurgTech Inc.                     510(k) NO: K163363(Traditional)
ATTN: Xuegong  Yu                 PHONE NO : 216 4212613 
24600 Center Ridge Road, Suite 195SE DECISION MADE: 05-APR-17
Westlake OH  44145                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RX Takeru Balloon Dilatation Catheter
KANEKA CORPORATION                510(k) NO: K163372(Traditional)
ATTN: Toshihiko  Motomine         PHONE NO : 81 3 55748023 
1-12-32, AKASAKA, MINATO-KU       SE DECISION MADE: 07-APR-17
TOKYO  JP 107-6028                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable
Edwards Lifesciences, LLC         510(k) NO: K163381(Traditional)
ATTN: Chirag  Shah                PHONE NO : 949 2501580 
One Edwards Way                   SE DECISION MADE: 14-APR-17
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System
GREENS SURGICALS PVT. LTD.        510(k) NO: K163383(Traditional)
ATTN: Vinay  Kumar                PHONE NO : 91 266 7264890 
209 (SECOND FLOOR), SAFFRON COMPLESE DECISION MADE: 19-APR-17
Vadodara  IN 390 002              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Keos Lumbar IBFD
Keos                              510(k) NO: K163386(Traditional)
ATTN: Mark F Schenk               PHONE NO : 610 5078255 
1824 Colonial Village Lane        SE DECISION MADE: 10-APR-17
Lancaster PA  17601               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PICO Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited    510(k) NO: K163387(Traditional)
ATTN: Samantha  Neilson           PHONE NO : 44 1482 673790 
101 Hessle Road                   SE DECISION MADE: 18-APR-17
Hull  GB HU3 2BN                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SlimShape System
Syneron Medical Ltd.              510(k) NO: K163415(Traditional)
ATTN: Ruthie  Amir                PHONE NO : 972 73 2442200 
Tavor Building, Industrial Zone, PSE DECISION MADE: 20-APR-17
Yokneam Illit  IL 20692           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension
ASAHI INTECC CO., LTD.            510(k) NO: K163426(Traditional)
ATTN: Yasuyuki  Kawahara          PHONE NO : 81 52 7681211 
1703 WAKITA-CHO, MORIYAMA-KU      SE DECISION MADE: 03-APR-17
NAGOYA  JP 463-0024               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Entellus Medical Reinforced Anesthesia Needle
Entellus Medical Inc.             510(k) NO: K163435(Traditional)
ATTN: Megan  Bernier              PHONE NO : 763 7625910 
3600 Holly Lane North, Suite 40   SE DECISION MADE: 05-APR-17
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Interson USB Ultrasound System
Interson Corporation              510(k) NO: K163443(Traditional)
ATTN: David  Asarnow              PHONE NO : 925 4624948 
7150 Koll Center Parkway          SE DECISION MADE: 13-APR-17
Pleasanton CA  94566              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zenysis Short-Term Dialysis Catheter
C.R BARD. INC.                    510(k) NO: K163458(Traditional)
ATTN: SILVIA  DE LA BARRA         PHONE NO : 801 5225909 
605 NORTH 5600 WEST               SE DECISION MADE: 04-APR-17
SALT LAKE CITY UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nihon Kohden Vital Sign Telemeter
Nihon Kohden Corporation          510(k) NO: K163459(Traditional)
ATTN: Tom  Bento                  PHONE NO : 949 6809048 
1-31-4 Nishiochiai, Shinjuku-Ku   SE DECISION MADE: 04-APR-17
Tokyo  JP 161-8560                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Coolief* Cooled RF Probe
Halyard Health, Inc.              510(k) NO: K163461(Traditional)
ATTN: Monica  King                PHONE NO : 678 4774165 
5405 Windward Parkway             SE DECISION MADE: 13-APR-17
Alpharetta GA  30004              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ViziShot 2 FLEX
Olympus Surgical Technologies Amer510(k) NO: K163469(Traditional)
ATTN: Mary Anne Patella           PHONE NO : 508 8042600 
136 Turnpike Road                 SE DECISION MADE: 06-APR-17
Southborough MA  01772-2104       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Paxman Scalp Cooler
Paxman Coolers Limited            510(k) NO: K163484(Traditional)
ATTN: Richard  PAXMAN             PHONE NO : 440 1484 349444 
International House, Penistone RoaSE DECISION MADE: 17-APR-17
Huddersfield  GB HD8 0LE          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Triton Sponge System
Gauss Surgical, Inc.              510(k) NO: K163507(Traditional)
ATTN: Artie  Kaushik              PHONE NO : 650 9494153 
334 State St., Suite 201          SE DECISION MADE: 25-APR-17
Los Altos CA  94022               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XprESS ENT Dilation System
Entellus Medical, Inc.            510(k) NO: K163509(Traditional)
ATTN: Karen E. Peterson           PHONE NO : 763 4637066 
3600 Holly Lane North, Suite 40   SE DECISION MADE: 05-APR-17
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Braun No Touch + Forehead NTF3000 Thermometer
Kaz USA, Inc., a Helen of Troy Com510(k) NO: K163516(Special)
ATTN: Rajesh  Kasbekar            PHONE NO : 508 4907280 
400 Donald Lynch Boulevard Suite 3SE DECISION MADE: 21-APR-17
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECHELON CIRCULAR Powered Stapler
Ethicon Endo-Surgery, LLC         510(k) NO: K163523(Traditional)
ATTN: Carmen  Ortiz               PHONE NO : 787 6534603 
475 Calle C                       SE DECISION MADE: 18-APR-17
Guaynabo PR  00969                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
Covidien llc                      510(k) NO: K163537(Traditional)
ATTN: LeeAnne  Swiridow           PHONE NO : 763 2104012 
161 Cheshire Lane, Suite 100      SE DECISION MADE: 21-APR-17
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MaxxiGold Electrode 48", MaxxiGold Electrode 60", MaxxiGold Electrode 96"
NEUROVIRTUAL USA, INC.            510(k) NO: K163547(Traditional)
ATTN: Eduardo  Faria              PHONE NO : 786 6938200 
2315 NW 107TH AVE SUITE #1M27     SE DECISION MADE: 11-APR-17
DORAL FL  33172                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navigated ELEVATE Inserter, Navigated Disc Prep Instruments
MEDTRONIC SOFAMOR DANEK USA, INC  510(k) NO: K163581(Traditional)
ATTN: LAVEEDA  LEFLORE            PHONE NO : 901 3963133 
1800 PYRAMID PLACE                SE DECISION MADE: 14-APR-17
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bluephase Style 20i
IVOCLAR VIVADENT, AG              510(k) NO: K163613(Abbreviated)
ATTN: SANDRA  CAKEBREAD           PHONE NO : 423 2353535 
BENDERERSTRASSE 2                 SE DECISION MADE: 04-APR-17
SCHAAN  LI FL-9494                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REMbrandt
Embla Systems                     510(k) NO: K163617(Traditional)
ATTN: Shane T Sawall              PHONE NO : 613 2548877 1301
1 Hines Road Suite 202            SE DECISION MADE: 11-APR-17
Kanata  CA K2K 3C7                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DERMABOND PRINEO Skin Closure System
Ethicon, LLC                      510(k) NO: K163645(Traditional)
ATTN: Joice  Pappan               PHONE NO : 908 2182113 
Route 22 West, P.O. Box 151       SE DECISION MADE: 21-APR-17
Somerville NJ  08876-0151         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension
Wright Medical Technology, Inc.   510(k) NO: K163650(Traditional)
ATTN: Rachel  Roberts             PHONE NO : 901 8679708 
1023 Cherry Road                  SE DECISION MADE: 24-APR-17
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hoffmann LRF System
Stryker GmbH                      510(k) NO: K163656(Traditional)
ATTN: Paul  Nelson                PHONE NO : 201 8315691 
325 Corporate Drive               SE DECISION MADE: 14-APR-17
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack)
HEALTH BEACONS, INC.              510(k) NO: K163667(Traditional)
ATTN: NANCY  CONFREY              PHONE NO : 978 2874635 
34 WALDEN STREET #753             SE DECISION MADE: 28-APR-17
CONCORD MA  01742                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Processor VP-7000, Light Source BL-7000
FUJIFILM Medical System U.S.A., In510(k) NO: K163675(Traditional)
ATTN: Shraddha S More             PHONE NO : 973 6862627 
10 High Point Drive               SE DECISION MADE: 25-APR-17
Wayne NJ  07470                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ortho System
3Shape A/S                        510(k) NO: K163677(Traditional)
ATTN: Hanne  Nielsen              PHONE NO : 45 70 272620 
Holmens Kanal 7                   SE DECISION MADE: 20-APR-17
Copenhagen  DK 1060               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K163690(Traditional)
ATTN: Yang  Zhaohui               PHONE NO : 86 755 81885640 
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 20-APR-17
ShenZhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OptiFix Open Absorbable Fixation System - 20 absorbable fasteners
C.R. BARD INC,                    510(k) NO: K163698(Traditional)
ATTN: KATHERINE  EARLE            PHONE NO : 401 8258450 
100 CROSSINGS BOULEVARD           SE DECISION MADE: 11-APR-17
WARWICK RI  02886                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QiF Blood and Fluid Warmer
Quality In Flow Ltd.              510(k) NO: K163708(Special)
ATTN: Neta  Sherman               PHONE NO : 972 54 6600146 
Kibutz Einat POB 29               SE DECISION MADE: 20-APR-17
Kibutz Einat  IL 4880500          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IQon Spectral CT
Philips Medical Systems (Cleveland510(k) NO: K163711(Traditional)
ATTN: Steven  Goldberg            PHONE NO : 972 072 3364218 
595 Miner Road                    SE DECISION MADE: 05-APR-17
Cleveland OH  44143               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Foot and Hand Motion
NEWCLIP TECHNICS                  510(k) NO: K170012(Traditional)
ATTN: Celine  CHEVRIER            PHONE NO : 33 2 28213712 
P.A. de la Lande Saint Martin, 45 SE DECISION MADE: 24-APR-17
Haute-Goulaine  FR F-44115        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BePOD Cannulated Arthrodesis Screws
Fournitures Hospitalieres Industri510(k) NO: K170040(Traditional)
ATTN: PATRICIA  DONNARD           PHONE NO : 33 298 556895 
ZI de Kernevez - 6 rue Nobel      SE DECISION MADE: 04-APR-17
Quimper  FR 29000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stellaris Elite vision enhancement system
Bausch + Lomb                     510(k) NO: K170052(Traditional)
ATTN: Dan  Regan                  PHONE NO : 636 7945013 
3365 Tree Ct. Industrial Blvd     SE DECISION MADE: 19-APR-17
St. Louis MO  63122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAPRI Corpectomy Cage System
K2M                               510(k) NO: K170055(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
600 Hope Parkway SE               SE DECISION MADE: 13-APR-17
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spectranetics Turbo-Elite Laser Atherectomy Catheters
Spectranetics, Inc.               510(k) NO: K170059(Traditional)
ATTN: Rebecca  Spelich            PHONE NO : 719 4472000 
9965 Federal Drive                SE DECISION MADE: 07-APR-17
Colorado Springs CO  80921        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AmCAD-UV
AmCad BioMed Corporation          510(k) NO: K170069(Traditional)
ATTN: Jack  Yang                  PHONE NO : 866 2 27136227 
FL.3, NO. 167, Fu Hsing N. RD.    SE DECISION MADE: 26-APR-17
Taipei  TW 105                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles
STERIS Corporation                510(k) NO: K170070(Traditional)
ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437 
5976 Heisley Rd                   SE DECISION MADE: 28-APR-17
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)
AirXpanders, Inc.                 510(k) NO: K170075(Traditional)
ATTN: Belinda  Pinedo             PHONE NO : 650 3908131 
1047 Elwell Ct.                   SE DECISION MADE: 03-APR-17
Palo Alto CA  94303               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film
MEDELA, AG                        510(k) NO: K170088(Traditional)
ATTN: Markus  Butler              PHONE NO : 41 041 5616671 
Lattichstrasse 4b                 SE DECISION MADE: 06-APR-17
Baar  CH 6341                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndoRotor
Interscope, Inc                   510(k) NO: K170120(Traditional)
ATTN: Jeffrey  Ryan               PHONE NO : 877 4207299 
100 Grove Street, Suite 108       SE DECISION MADE: 18-APR-17
Worchester MA  01605              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyoCycle Home, MyoCycle Pro
MYOLYN, LLC                       510(k) NO: K170132(Traditional)
ATTN: Matthew  Bellman            PHONE NO : 352 3542749 
7731  W. Newberry Rd., Suite A-2  SE DECISION MADE: 25-APR-17
Gainesville FL  32606             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital TENS Unit
SHENZHEN EAPPLY TECHNOLOGY CO., LT510(k) NO: K170145(Traditional)
ATTN: LISA  HUANG                 PHONE NO : 86 755 33919819 817
3RD FLOOR, 2ND BUILDING, HEZHOU NESE DECISION MADE: 29-APR-17
SHENZHEN CITY  CN 518000          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IOLMaster 700
Carl Zeiss Meditec AG             510(k) NO: K170171(Traditional)
ATTN: Christian  Muenster         PHONE NO : 49 7364 206985 
Goeschwitzer Strasse 51-52        SE DECISION MADE: 06-APR-17
Jena  DE 07445                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Insight Dental System
Insight Dental System             510(k) NO: K170211(Traditional)
ATTN: Matthew  Kaupp              PHONE NO : 210 8122323 
4766 Research Drive               SE DECISION MADE: 27-APR-17
San Antonio TX  78240             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Additive Orthopaedics Locking Lattice Plate
Additive Orthopaedics, LLC        510(k) NO: K170214(Traditional)
ATTN: Greg  Kowalczyk             PHONE NO : 732 8826633 
83 Amelia Circle                  SE DECISION MADE: 13-APR-17
Little Silver NJ  07739           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock
Patient Pocket LLC                510(k) NO: K170215(Traditional)
ATTN: Allen D. Seftel             PHONE NO : 216 2720805 
405 Hialeah Dr                    SE DECISION MADE: 19-APR-17
Cherry Hill NJ  08002             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OneQ-SL s-Clean Implant System
DENTIS CO., LTD.                  510(k) NO: K170220(Traditional)
ATTN: SUN CHU SHIN                PHONE NO : 82 535 822804 
99, SEONGSEOSEO-RO, DALSEO-GU     SE DECISION MADE: 27-APR-17
DAEGU  KR 42718                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.CT Cardiac Planning
Siemens Healthcare GmbH           510(k) NO: K170221(Third Party - Traditional)
ATTN: Martin  Knoppik             PHONE NO : 49 9191 186946 
Siemensstr. 1                     SE DECISION MADE: 21-APR-17
Forchheim  DE 91301               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Lacriflow CL
KANEKA PHARMA AMERICA LLC         510(k) NO: K170247(Special)
ATTN: Masaaki  Fukunishi          PHONE NO : 212 7054343 
546 FIFTH AVE., 21ST FLOOR        SE DECISION MADE: 18-APR-17
NEW YORK NY  10036                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Threshold™ Pedicular Fixation System
SPINEOLOGY INC.                   510(k) NO: K170251(Traditional)
ATTN: JACQUELINE  HAUGE           PHONE NO : 651 2568500 
7800 3RD STREET N SUITE 600       SE DECISION MADE: 14-APR-17
ST.PAUL MN  55128                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Threshold™ V2 Pedicular Fixation System
SPINEOLOGY INC.                   510(k) NO: K170255(Traditional)
ATTN: JACQUELINE  HAUGE           PHONE NO : 651 2568500 
7800 3RD STREET N SUITE 600       SE DECISION MADE: 14-APR-17
ST. PAUL MN  55128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BC-001+ Acne Purifier
Oriental Inspiration Limited      510(k) NO: K170260(Traditional)
ATTN: Andy  Wu                    PHONE NO : 852 2654 0872 
Unit 607, The Lakeside 2, West WinSE DECISION MADE: 25-APR-17
Hong Kong  CN                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Palisade™ Pedicular Fixation System
Spineology Inc.                   510(k) NO: K170266(Traditional)
ATTN: Jacqueline  Hauge           PHONE NO : 651 2568500 
7800 3rd Street N, Suite 600      SE DECISION MADE: 14-APR-17
St. Paul MN  55128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fortress™ Pedicular Fixation System
Spineology Inc.                   510(k) NO: K170268(Traditional)
ATTN: Jacqueline  Hauge           PHONE NO : 651 2568500 
7800 3rd Street N, Suite 600      SE DECISION MADE: 14-APR-17
St. Paul MN  55128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Z-DOSE29
ZETTA MEDICAL TECHNOLOGIES, LLC.  510(k) NO: K170273(Traditional)
ATTN: MAIN M. GHAZAL              PHONE NO : 1 847 5509990 
1313 ENSELL ROAD                  SE DECISION MADE: 28-APR-17
LAKE ZURICH IL  60047             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smith & Nephew SURESHOT Distal Targeting System V4.0
Smith & Nephew, Inc.              510(k) NO: K170280(Traditional)
ATTN: Allison  Chan               PHONE NO : 901 3991098 
1450 East Brooks Road             SE DECISION MADE: 28-APR-17
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Restrata Wound Matrix
Acera Surgical, Inc.              510(k) NO: K170300(Traditional)
ATTN: Tamas  Kovacs               PHONE NO : 844 8792237 
10880 Baur Blvd.                  SE DECISION MADE: 26-APR-17
St. Louis MO  63132               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acuson SC2000 Diagnostic Ultrasound System
Siemens Medical Solutions Inc.    510(k) NO: K170315(Third Party - Special)
ATTN: Kevin  Kong                 PHONE NO : 650 9699112 
685 East Middlefield Road         SE DECISION MADE: 04-APR-17
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CD HORIZON™ Fenestrated Screw Set
Medtronic Sofamor Danek USA       510(k) NO: K170347(Traditional)
ATTN: Lee  Grant                  PHONE NO : 901 3440807 
1800 Pyramid Place                SE DECISION MADE: 04-APR-17
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: joimax Endovapor 2
joimax GmbH                       510(k) NO: K170358(Traditional)
ATTN: Wolfgang  Ries              PHONE NO : 49 0721 255140 
Amalienbadstr. 41, RaumFabrik 61  SE DECISION MADE: 21-APR-17
Karlsruhe  DE 76227               510(k) STATEMENT
                                                    

DEVICE: TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM
Richard Wolf Medical Instruments C510(k) NO: K170377(Traditional)
ATTN: Mike  Loiterman             PHONE NO : 847 9131113 
353 Corporate Woods Parkway       SE DECISION MADE: 05-APR-17
Vernon Hills IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CORE M2 Vascular System
Volcano Corporation               510(k) NO: K170385(Special)
ATTN: Courtney  Moore             PHONE NO : 858 7641308 
3721 Valley Centre Dr Ste 500     SE DECISION MADE: 06-APR-17
San Diego CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle
Becton, Dickinson & Company       510(k) NO: K170386(Special)
ATTN: Riddhish  Patel             PHONE NO : 201 8475571 
1 Becton Drive                    SE DECISION MADE: 12-APR-17
Franklin Lakes NJ  07666          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Plato MICROCATH 27B Microcatheter
Scientia Vascular LLC             510(k) NO: K170406(Third Party - Traditional)
ATTN: David  Sabodski             PHONE NO : 888 3859016 
3487 West 2100 South Suite 100    SE DECISION MADE: 18-APR-17
West Valley City UT  84119        510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ER-REBOA Catheter
Prytime Medical Devices, Inc      510(k) NO: K170411(Traditional)
ATTN: Brian  Young                PHONE NO : 210 2163020 
229 North Main Street             SE DECISION MADE: 04-APR-17
Boerne TX  78006                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOGIQ S8
GE Healthcare                     510(k) NO: K170445(Traditional)
ATTN: Bryan  Behn                 PHONE NO : 414 7214214 
9900 Innovation Dr.               SE DECISION MADE: 11-APR-17
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
Stryker Sustainability Solutions  510(k) NO: K170456(Traditional)
ATTN: Chelsea  Cullen             PHONE NO : 888 8883433 5506
1810 W Drake Drive                SE DECISION MADE: 05-APR-17
Tempe AZ  85283                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bausch + Lomb Sensitive Eyes Plus Saline Solution
Bausch & Lomb Incorporated        510(k) NO: K170483(Traditional)
ATTN: Melissa  Thomas             PHONE NO : 585 3386045 
1400 North Goodman Street         SE DECISION MADE: 11-APR-17
Rochester NY  14609               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Patient Positioning System
Forte Automation Systems, Inc.    510(k) NO: K170502(Special)
ATTN: Phil  Reece                 PHONE NO : 815 6332300 
8155 Burden Rd                    SE DECISION MADE: 13-APR-17
Machesney Park IL  61115          510(k) STATEMENT
                                                    

DEVICE: NeoFuse HA Enhanced PLIF/TLIF
HT Medical, LLC                   510(k) NO: K170511(Special)
ATTN: Robert  Compton             PHONE NO : 918 9952090 
6316 E 102nd Street               SE DECISION MADE: 25-APR-17
Tulsa OK  74137                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Model 330 Multifunction Aspirator
ZOLL Medical Corporation          510(k) NO: K170533(Traditional)
ATTN: Pooja  Dalvi                PHONE NO : 978 8056293 
269 & 271 Mill Road               SE DECISION MADE: 18-APR-17
Chelmsford MA  01824-4105         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECG Disposable Lead Wire
APK Technology Co., Ltd.          510(k) NO: K170536(Traditional)
ATTN: Caifang  Wang               PHONE NO : 86 755 27325581 
6Floor, B2 Building, Industry of HSE DECISION MADE: 24-APR-17
Shenzhen  CN 518126               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nexxis OR, Nexxis
Barco n.v.                        510(k) NO: K170537(Special)
ATTN: Eric  Caus                  PHONE NO : 32 5 6233349 
Beneluxpark 21                    SE DECISION MADE: 21-APR-17
Kortrijk  BE 8500                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SAGE Vitrification Kit and SAGE Vitrification Warming Kit
CooperSurgical Inc                510(k) NO: K170560(Special)
ATTN: Tove  Kjær                  PHONE NO : 45 4679 0220 
95 Corporate Drive                SE DECISION MADE: 04-APR-17
Trumbull CT  06611                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Summit Spine Yellowstone Lumbar Interbody Fusion System
Summit Spine                      510(k) NO: K170572(Traditional)
ATTN: Eric  Buescher              PHONE NO : 877 2089272 
2333 Airport Rd                   SE DECISION MADE: 26-APR-17
Georgetown TX  78628              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Carestream Vue PACS
Carestream Health, Inc.           510(k) NO: K170580(Traditional)
ATTN: Diane  Koetter              PHONE NO : 585 6276505 
150 Verona Street                 SE DECISION MADE: 11-APR-17
Rochester NY  14608               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Saf-T-Vac Smoke and Fluid Evacuator
Surgical Technology Laboratories, 510(k) NO: K170582(Traditional)
ATTN: Mathew  Fairfax             PHONE NO : 803 4621714 
1566 Whiting Way                  SE DECISION MADE: 14-APR-17
Lugoff SC  29078                  510(k) STATEMENT
                                                    

DEVICE: NuVasive BASE Interfixated Titanium System
NuVasive, Incorporated            510(k) NO: K170592(Traditional)
ATTN: Cynthia  Adams              PHONE NO : 858 3204549 
7475 Lusk Blvd.                   SE DECISION MADE: 26-APR-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mako Total Hip Application
MAKO Surgical Corp.               510(k) NO: K170593(Special)
ATTN: Shikha  Khandelwal          PHONE NO : 201 8316921 
2555 Davie Rd                     SE DECISION MADE: 18-APR-17
Fort Lauderdale FL  33317         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZeroWire Mobile
NDS Surgical Imaging, LLC.        510(k) NO: K170598(Special)
ATTN: Shala  Famil                PHONE NO : 408 7760085 
5750 Hellyer Ave                  SE DECISION MADE: 07-APR-17
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PlasmaBlade T
Medtronic Advanced Energy         510(k) NO: K170610(Traditional)
ATTN: Lydia  Sakakeeny            PHONE NO : 603 2945482 
180 International Drive           SE DECISION MADE: 13-APR-17
Portsmouth NH  03801              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: van Andel Dilatation Catheter
Cook Incorporated                 510(k) NO: K170616(Traditional)
ATTN: Daniel J. Corbin            PHONE NO : 812 3353575 104018
750 Daniels Way                   SE DECISION MADE: 28-APR-17
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System
RTI Surgical, Inc. dba RTI Biologi510(k) NO: K170643(Traditional)
ATTN: Jennifer  Bonacci           PHONE NO : 386 4188888 4208
11621 Research Circle             SE DECISION MADE: 14-APR-17
Alachua FL  32615                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HeartSpan Steerable Sheath Introducer
Merit Medical Systems, Inc.       510(k) NO: K170668(Special)
ATTN: Alina  Stubbs               PHONE NO : 610 6515046 
65 Great Valley Parkway           SE DECISION MADE: 05-APR-17
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neurovision Nerve Locator Monitor (Nerveana), EMGView Software
Neurovision Medical Product Inc.  510(k) NO: K170677(Special)
ATTN: Christine  Vergely          PHONE NO : 866 8156999 
353 San Jon Rd                    SE DECISION MADE: 05-APR-17
Ventura CA  93001                 510(k) STATEMENT
                                                    

DEVICE: Beta-CrossLaps CalCheck 5
Roche Diagnostics                 510(k) NO: K170678(Traditional)
ATTN: Edie  Brunt                 PHONE NO : 317 5214668 
9115 Hague Road                   SE DECISION MADE: 04-APR-17
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Inqwire Diagnostic Guide Wire
Merit Medical Systems Inc.        510(k) NO: K170700(Special)
ATTN: Mark  Mullaney              PHONE NO : 353 91 703700 3061
Parkmore Business Park West       SE DECISION MADE: 06-APR-17
Galway  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PercuNav Image Fusion and Interventional Navigation
Philips Ultrasound Inc.           510(k) NO: K170716(Third Party - Traditional)
ATTN: Peng  Cui                   PHONE NO : 978 6597966 
3000 Minuteman Road               SE DECISION MADE: 21-APR-17
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Anzai Respiratory Gating System
Anzai Medical Co., Ltd.           510(k) NO: K170719(Special)
ATTN: Naoya  Iwasaki              PHONE NO : 81 337 791611 
3-9-15 Nishi-Shinagawa Shinagawa-kSE DECISION MADE: 05-APR-17
Tokyo  JP 141-0033                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil
Precision Surgical, LLC           510(k) NO: K170721(Third Party - Traditional)
ATTN: Prash  Jayaraj              PHONE NO : 702 9438905 
245 E Warm Springs Rd, #132       SE DECISION MADE: 21-APR-17
Las Vegas NV  89119               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: NeuroBlate System
Monteris Medical                  510(k) NO: K170724(Special)
ATTN: David H. Mueller            PHONE NO : 763 2534710 
14755 27th Avenue North Suite C   SE DECISION MADE: 07-APR-17
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight
Vatech Co., Ltd                   510(k) NO: K170731(Traditional)
ATTN: Daniel  Kim                 PHONE NO : 82 31 3799585 
13, Samsung 1-ro 2-gil            SE DECISION MADE: 04-APR-17
Hwaseong-si  KR 445-170           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MX50N(MX50YQS)
WIDE Corporation                  510(k) NO: K170781(Traditional)
ATTN: YeoJin  Yun                 PHONE NO : 82 31 2181675 
12 Wongomae-Ro, Giheung-Gu        SE DECISION MADE: 04-APR-17
Yongin-Si  KR 17086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CyberKnife Treatment Delivery System
Accuray Incorportaed              510(k) NO: K170788(Traditional)
ATTN: Jyoti  Singh                PHONE NO : 408 7164660 
1310 Chesapeake Terrace           SE DECISION MADE: 11-APR-17
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORTHOPANTOMOGRAPH OP 3D
PaloDEx Group Oy                  510(k) NO: K170813(Traditional)
ATTN: Terho  Turkumaki            PHONE NO : 358 10 2702000 
Nahkelantie 160                   SE DECISION MADE: 07-APR-17
Tuusula  FI 04300                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndoFLIP® System with FLIP Topography module
Crospon Ltd.                      510(k) NO: K170833(Special)
ATTN: John  O’Dea                 PHONE NO : 011 353 91519882 
Galway Business Park, Dangan      SE DECISION MADE: 17-APR-17
Galway  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nio Color 3MP (MDNC-3421)
Barco NV                          510(k) NO: K170837(Special)
ATTN: Helena  Soenen              PHONE NO : 32 56 233528 
President Kennedypark 35          SE DECISION MADE: 05-APR-17
Kortrijk  BE 8500                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FDR AQRO (DR-XD 1000)
FUJIFILM Medical Systems U.S.A., I510(k) NO: K170858(Traditional)
ATTN: Peter  Altman               PHONE NO : 1 203 6023576 
419 West Avenue                   SE DECISION MADE: 24-APR-17
Stamford CT  06902                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories
Intuitive Surgical, Inc.          510(k) NO: K170865(Traditional)
ATTN: Cheryl  Wu                  PHONE NO : 408 5236401 
1266 Kifer Road                   SE DECISION MADE: 21-APR-17
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated
Covidien                          510(k) NO: K170869(Special)
ATTN: Celso  Duran                PHONE NO : 303 5306445 
5920 Longbow Drive                SE DECISION MADE: 21-APR-17
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ABL90 FLEX, ABL90 FLEX PLUS
Radiometer Medical ApS            510(k) NO: K170882(Traditional)
ATTN: Soren  Boegestrand          PHONE NO : 45 38 273852 
Aakandevej 21                     SE DECISION MADE: 28-APR-17
Broenshoej  DK DK-2700            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVOS Small Fragment Plating System
Smith & Nephew, Inc.              510(k) NO: K170887(Special)
ATTN: Samantha  Staubach          PHONE NO : 901 3996132 
1450 Brooks Road                  SE DECISION MADE: 24-APR-17
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HV Screw System
Wright Medical Technology, Inc.   510(k) NO: K170889(Traditional)
ATTN: Tara  Conrad                PHONE NO : 901 8674367 
1023 Cherry Road                  SE DECISION MADE: 26-APR-17
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Star Tissue Marker
Scion Medical Technologies, LLC   510(k) NO: K170905(Special)
ATTN: Louis  Li                   PHONE NO : 888 5826211 
4613 West Chester Pike            SE DECISION MADE: 27-APR-17
Newtown Square PA  19073          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BrainPulse 1100
Jan Medical, Inc.                 510(k) NO: K170926(Special)
ATTN: Prabhu  Raghavan            PHONE NO : 650 3168811 
110 Pioneer Way, Suite L          SE DECISION MADE: 28-APR-17
Mountain View CA  94041           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RSM 2430C
DRTECH Corporation                510(k) NO: K170930(Special)
ATTN: Choul-Woo  Shin             PHONE NO : 82 31 7797783 
Suit No. 2, 3 Floor, 29, Dunchon-dSE DECISION MADE: 27-APR-17
Seongnam-si  KR 13230             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cutera enlighten III Laser System
Cutera, Inc.                      510(k) NO: K170936(Special)
ATTN: Bradley  Renton             PHONE NO : 415 6575568 
3240 Bayshore Blvd.               SE DECISION MADE: 25-APR-17
Brisbane CA  94005                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CalSet IGF-1
Roche Diagnostics                 510(k) NO: K170938(Traditional)
ATTN: Lisa K. Klinedinst          PHONE NO : 317 5211942 
9115 Hague Road                   SE DECISION MADE: 26-APR-17
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
Choice Spine, LP                  510(k) NO: K170942(Special)
ATTN: Kim  Finch                  PHONE NO : 865 2433969 
400 Erin Drive                    SE DECISION MADE: 26-APR-17
Knoxville TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biodesign Staple Line Reinforcement
Cook Biotech Incorporated         510(k) NO: K170945(Special)
ATTN: Perry W. Guinn              PHONE NO : 765 4973355 
1425 Innovation Place             SE DECISION MADE: 28-APR-17
West Lafayette IN  47906          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RadiForce MX315W
EIZO Corporation                  510(k) NO: K170949(Traditional)
ATTN: Hiroaki  Hashimoto          PHONE NO : 81 76 2742468 
153 Shimokashiwano                SE DECISION MADE: 27-APR-17
Hakusan  JP 924-8566              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CardioCel 3D
Admedus Regen Pty Ltd             510(k) NO: K170951(Special)
ATTN: Mary E. Donlin              PHONE NO : 61 08 92660100 
26 Harris Road                    SE DECISION MADE: 28-APR-17
Malaga  AU 6090                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.CT View&GO
Siemens Medical Solutions USA, Inc510(k) NO: K170952(Traditional)
ATTN: Kimberly  Mangum            PHONE NO : 610 4486477 
40 Liberty Blvd., Mail Code 65-1 ASE DECISION MADE: 28-APR-17
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tomcat Cervical Spinal System
Choice Spine, LP                  510(k) NO: K170953(Special)
ATTN: Kim  Finch                  PHONE NO : 865 2463333 
400 Erin Drive                    SE DECISION MADE: 21-APR-17
Knoxville TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zenius Spinal System
Medyssey USA, Inc.                510(k) NO: K170964(Special)
ATTN: Shawn  Kim                  PHONE NO : 1 847 4270200 
1550 East Higgins Road Suite 123  SE DECISION MADE: 26-APR-17
Elk Grove Village IL  60007       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exactech® Truliant™ Line Extensions
Exactech, Inc.                    510(k) NO: K171045(Special)
ATTN: Patrick  Hughes             PHONE NO : 352 3274762 
2320 NW 66th Court                SE DECISION MADE: 28-APR-17
Gainesville FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    


            TOTAL 510(k)s THIS PERIOD   245                                     
            TOTAL WITH SUMMARIES        232                                     
            TOTAL WITH STATEMENTS        13