Medical Devices

January 2016 510(k) Clearances

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


DEVICE: POCKET NEB
MicroVaper Devices                510(k) NO: K142541(Abbreviated)
ATTN: Scott  Faris                PHONE NO : 
2682 West Fairbanks Ave.          SE DECISION MADE: 22-JAN-16
Winter Park FL  32789             510(k) STATEMENT
                                                    

DEVICE: URight Hemoglobin A1c system, FORA A1c System
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K142664(Traditional)
ATTN: C.W.   Chen                 PHONE NO : 886 2 66258188 
B1-7F , No.127, Wugong 2nd Rd., WuSE DECISION MADE: 29-JAN-16
New Taipei City  TW 24888         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VENTURI MiNO TG600/14
TALLEY GROUP LTD.                 510(k) NO: K143004(Traditional)
ATTN: ROBERT WILLIAM MACDONALD    PHONE NO : 011 44 1794503575 
PREMIER WAY, ABBEY PARK INDUSTRIALSE DECISION MADE: 05-JAN-16
ROMSEY  GB SO51 9DQ               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SonarMed AirWave, Airway Monitoring System
SONARMED, INC.                    510(k) NO: K143042(Traditional)
ATTN: Laura  Lyons                PHONE NO : 317 4893161 
12220 N. Meridian St., Ste. 150   SE DECISION MADE: 22-JAN-16
Carmel IN  46032                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K143153(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 ISHIKAWA-CHO                 SE DECISION MADE: 15-JAN-16
HACHIOJI-SHI  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyGlucoHealth Wireless System
ENTRA HEALTH SYSTEMS              510(k) NO: K143169(Special)
ATTN: RICHARD   STROBRIDGE        PHONE NO : 1 877 4582646 
3111 Camino Del Rio North Suite 10SE DECISION MADE: 08-JAN-16
San Diego CA  92108               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tellos ISQ Buddy
Tellos Medical AB                 510(k) NO: K143445(Traditional)
ATTN: Anders  Petersson           PHONE NO : 46 709 741269 
Nedergardsgatan 5                 SE DECISION MADE: 07-JAN-16
Goteborg  SE 41654                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set
DIAZYME LABORATORIES              510(k) NO: K143470(Traditional)
ATTN: Abhijit  Datta              PHONE NO : 858 4554762 
12889 GREGG COURT                 SE DECISION MADE: 31-JAN-16
POWAY CA  92064                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Antistatic Compact Space Chamber
MEDICAL DEVELOPMENTS INTERNATIONAL510(k) NO: K143615(Traditional)
ATTN: MAGGIE  OH                  PHONE NO : 61 421 949179 
7/56 SMITH ROAD                   SE DECISION MADE: 26-JAN-16
SPRINGVALE  AU 3171               510(k) STATEMENT
                                                    

DEVICE: Lustre PRO Light System
AMBICARE HEALTH LTD               510(k) NO: K143713(Traditional)
ATTN: Neil  MacGilp               PHONE NO : 44 01506 592239 
Alba Innovation Centre, Alba CampuSE DECISION MADE: 19-JAN-16
Livingston  GB EH54 7GA           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TheraVision Ultrasound Ablation System and ACOUSTx Applicators
ACOUSTIC MEDSYSTEMS, INC.         510(k) NO: K150019(Traditional)
ATTN: Yvonne  Schleife            PHONE NO : 217 2390900 
208 BURWASH AVE.                  SE DECISION MADE: 13-JAN-16
SAVOY IL  61874                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GluStitch Twist Tissue Adhesive 
GLUSTITCH, INC.                   510(k) NO: K150032(Traditional)
ATTN: DON  BLACKLOCK              PHONE NO : 604 9401057 
#307-7188 PROGRESS WAY            SE DECISION MADE: 14-JAN-16
DELTA  CA V4G 1M6                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VIVACE Electrosurgical System
Sung Hwan E&B Co.,Ltd             510(k) NO: K150409(Traditional)
ATTN: Sun Young Kang              PHONE NO : 82 2 4660010 
SK Techno Bld Suite #502 ,16-4 SeoSE DECISION MADE: 15-JAN-16
Seongdong-Gu  KR 133710           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FloSure Ventilation Patch
SIMEX MEDIZINTECHNIK GmbH         510(k) NO: K150459(Traditional)
ATTN: Hamid  Khosrowshahi         PHONE NO : 914 7727326 
Post Box 1207                     SE DECISION MADE: 05-JAN-16
DEISSLINGEN  DE D-78649           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Discovery 24
BRAINMASTER TECHNOLOGIES, INC.    510(k) NO: K150498(Traditional)
ATTN: Mr. Tom  Collura            PHONE NO : 440 2326000 205
195 Willis Street, Suite 3        SE DECISION MADE: 26-JAN-16
Bedford OH  44146                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IQSense Flow Sensor Mouthpiece
SDI DIAGNOSTICS, INC.             510(k) NO: K150515(Traditional)
ATTN: COSIMO  CARIOLO             PHONE NO : 508 2387033 
10 HAMPDEN DRIVE                  SE DECISION MADE: 12-JAN-16
EASTON MA  02375                  510(k) STATEMENT
                                                    

DEVICE: VistaCam iX "Proof"
Durr Dental AG                    510(k) NO: K150672(Traditional)
ATTN: Oliver  Lange               PHONE NO : 49 7142 7050 
Hopfigheimer Strasse 17           SE DECISION MADE: 27-JAN-16
Bietigheim-Bissingen  DE D-74321  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sysmex Automated Blood Coagulation Analyzer CS-5100
Siemens Healthcare Diagnostic Prod510(k) NO: K150678(Traditional)
ATTN: DONNA  NOEH                 PHONE NO : 49 64213 95107 
EMIL-VON-BEHRING-STR. 76          SE DECISION MADE: 11-JAN-16
MARBURG  DE 35041                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Shape-HF Cardiopulmonary Testing System
SHAPE MEDICAL SYSTEMS, INC        510(k) NO: K150888(Traditional)
ATTN: BERNARD  HORWATH            PHONE NO : 1 651 2311761 
5000 TOWNSHIP PARKWAY             SE DECISION MADE: 21-JAN-16
MINNEAPOLIS MN  55110             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IntelliCuff
HAMILTON MEDICAL AG               510(k) NO: K150893(Traditional)
ATTN: STEFFEN  BODEN              PHONE NO : 41 58 6101842 
VIA CRUSCH 8                      SE DECISION MADE: 29-JAN-16
BONADUZ  CH 7402                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces
KARL STORZ ENDOSCOPY AMERICA, INC.510(k) NO: K150969(Traditional)
ATTN: Jennifer Michelle Chambers  PHONE NO : 424 2188457 
2151 E. GRAND AVE                 SE DECISION MADE: 08-JAN-16
EL SEGUNDO CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette
COOK INCORPORATED                 510(k) NO: K151018(Traditional)
ATTN: Naomi  Funkhouser           PHONE NO : 812 3353575 104371
750 DANIELS WAY                   SE DECISION MADE: 08-JAN-16
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Phadia Prime
PHADIA AB                         510(k) NO: K151029(Special)
ATTN: Anna-Lisa  Tiensuu          PHONE NO : 46 18 165000 
RAPSGATAN 7P                      SE DECISION MADE: 19-JAN-16
UPPSALA  SE 75137                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ATLANTIS Abutment for NobelActive 3.0
DENTSPLY INTERNATIONAL, INC.      510(k) NO: K151039(Traditional)
ATTN: HELEN  LEWIS                PHONE NO : 717 4871332 
SUSQUEHANNA COMMERCE CTR., 221 W. SE DECISION MADE: 14-JAN-16
YORK PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set
BRACCO INJENEERING                510(k) NO: K151048(Traditional)
ATTN: MAUD  GIORGI                PHONE NO : 41 21 6217400 
AVENUE DE SEVELIN 46              SE DECISION MADE: 22-JAN-16
LAUSANNE  CH CH-1004              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Universa Soft Ureteral Stents and Stent Sets
COOK INCORPORATED                 510(k) NO: K151051(Traditional)
ATTN: Jamie  Ridner               PHONE NO : 812 3353575 102834
750 DANIELS WAY                   SE DECISION MADE: 11-JAN-16
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sonishield 100 Antimicrobial Ultrasound Gel
Quotient Medical                  510(k) NO: K151070(Traditional)
ATTN: David  Okamoto              PHONE NO : 416 8436177 
3365 Harvester Road, Suite 110    SE DECISION MADE: 13-JAN-16
Burlington  CA L7N 3N2            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit
Solo-Dex, Inc.                    510(k) NO: K151072(Traditional)
ATTN: Siddarth  Desai             PHONE NO : 949 3227168 
3 Moonlight Isle                  SE DECISION MADE: 22-JAN-16
Ladera Ranch CA  92694            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BR-ABVS Viewer 1.0
TAIHAO MEDICAL INC.               510(k) NO: K151075(Traditional)
ATTN: HSIN HUNG(SIMON) LAI        PHONE NO : 886 2 28582357 
7F., NO.410, SEC.5M ZHONGXIAO E. RSE DECISION MADE: 15-JAN-16
TAIPEI  TW                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge
Cardica, Inc.                     510(k) NO: K151081(Traditional)
ATTN: Vee  Arya                   PHONE NO : 650 6447339 
900 Saginaw Drive                 SE DECISION MADE: 15-JAN-16
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioBridge Collagen Matrix
Fibralign Corporation             510(k) NO: K151083(Traditional)
ATTN: Greg  King                  PHONE NO : 510 4892199 
32930 Alvarado-Niles Road, Suite 3SE DECISION MADE: 08-JAN-16
Union City CA  94587              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Well Lead Ureteral Access Sheath
WELL LEAD MEDICAL CO. LTD         510(k) NO: K151084(Traditional)
ATTN: HUANG KAI GEN               PHONE NO : 86 20 84758878 
C-4 JINHU INDUSTRIAL ESTATE HUALONSE DECISION MADE: 07-JAN-16
GUANGZHOU  CN 511434              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OTELO LL
SPINEART                          510(k) NO: K151104(Traditional)
ATTN: Franck  Pennesi             PHONE NO : 41 22570 1246 
INTERNATIONAL CENTER COINTRIN 20 RSE DECISION MADE: 06-JAN-16
Geneve  CH 1215                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cronus HP - High Pressure Peripheral Balloon Catheter
NIPRO MEDICAL CORPORATION         510(k) NO: K151141(Traditional)
ATTN: JESSICA  OSWALD-MCLEOD      PHONE NO : 305 5997174 
3150 NW 107TH AVE.                SE DECISION MADE: 14-JAN-16
DORAL FL  33172                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImplantMax Software
SATURN IMAGING INC.               510(k) NO: K151152(Traditional)
ATTN: BEENDER  YANG               PHONE NO : 886 2 86983330 
79, SEC. 1, XINTAI 5TH RD., 14F-11SE DECISION MADE: 12-JAN-16
NEW TAIPEI CITY  TW 22101         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KLOCKNER DENTAL IMPLANT ABUTMENTS (II)
SOADCO, S.L.                      510(k) NO: K151194(Abbreviated)
ATTN: Maria  Mitjaneta            PHONE NO : 376 800 590 
AVGDA FITER I ROSELL., 4 BIS-LOCALSE DECISION MADE: 29-JAN-16
ESCALDES-ENGORDANY  AD AD-700     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm
EMERSON & CO. S.R.L.              510(k) NO: K151228(Traditional)
ATTN: Stefano  Costigliolo        PHONE NO : 39 010 5386400 
PIAZZA DELLA VITTORIA, 10         SE DECISION MADE: 15-JAN-16
GENOA  IT 16121                   510(k) STATEMENT
                                                    

DEVICE: Sysmex Automated Blood Coagulation Analyzer CS-2100i
SIEMENS HEALTHCARE DIAGNOSTICS PRO510(k) NO: K151259(Traditional)
ATTN: NILS  NEUMANN               PHONE NO : 49 64 21397133 
EMIL-VON BEHRING-STR. 76          SE DECISION MADE: 26-JAN-16
MARBURG  DE 35041                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECG Mini System Continuous ECG Monitor and Arrhythmia Detector
LifeWatch Technologies Ltd.       510(k) NO: K151269(Traditional)
ATTN: Asher  Kassel               PHONE NO : 972 8 9484000 
2 Pekeris St.                     SE DECISION MADE: 15-JAN-16
Rehovot  IL 0202                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InMode FRF Applicator
Inmode MD Ltd.                    510(k) NO: K151273(Traditional)
ATTN: Ahava  Stein                PHONE NO : 972 4 9097470 
Tabor Building Shaar Yokneam      SE DECISION MADE: 04-JAN-16
Yoqneam Illit  IL 2069200         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: core nova Complete Operating Room Endoscopy
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K151282(Traditional)
ATTN: MICHELE  MCDONALD           PHONE NO : 1 847 9131113 380
353 CORPORATE WOODS PKWY.         SE DECISION MADE: 12-JAN-16
VERNON HILLS IL  60061-3110       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D
GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K151287(Traditional)
ATTN: Jin  Liang                  PHONE NO : 86 756 3399967 
INNOVATION FIRST ROAD TECHNOLOGY ISE DECISION MADE: 06-JAN-16
ZHUHAI  CN 519085                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AirLife Infant Heated Wire Circuit
CAREFUSION                        510(k) NO: K151303(Traditional)
ATTN: ERIKA  FERNANDEZ            PHONE NO : 847 3628097 
75 NORTH FAIRWAY DRIVE            SE DECISION MADE: 21-JAN-16
VERNON HILLS IL  60047            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Amendia Interbody Fusion Devices
AMENDIA, INC.                     510(k) NO: K151310(Traditional)
ATTN: BRUCE   HOOPER              PHONE NO : 877 7553329 
1755 WEST OAK PARKWAY             SE DECISION MADE: 06-JAN-16
MARIETTA GA  30062                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VerteLP Interbody Fusion Device
VGI, LLC                          510(k) NO: K151312(Traditional)
ATTN: Tov  Vestgaarten            PHONE NO : 813 2830909 
150 253rd Ave                     SE DECISION MADE: 13-JAN-16
St. Petersburg FL  33708          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml
BECTON, DICKINSON AND COMPANY     510(k) NO: K151320(Traditional)
ATTN: MONICA E. GIGUERE           PHONE NO : 1 410 3164287 
7 LOVETON CIRCLE MC 694           SE DECISION MADE: 15-JAN-16
SPARKS MD  21152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PURE Ceramic Implants
STRAUMANN USA                     510(k) NO: K151328(Traditional)
ATTN: CHRIS   KLACZYK             PHONE NO : 978 7472575 
60 MINUTEMAN ROAD                 SE DECISION MADE: 11-JAN-16
ANDOVER MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cervello STIM
BLACKROCK NEUROMED                510(k) NO: K151354(Traditional)
ATTN: SHANNA  RYAN                PHONE NO : 801 9445661 
630 KOMAS DRIVE, SUITE 200        SE DECISION MADE: 27-JAN-16
SALT LAKE CITY UT  84108          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sydney IVF Hyaluronidase
WILLIAM A. COOK AUSTRALIA PTY LTD 510(k) NO: K151367(Traditional)
ATTN: GORDANA  POZVEK             PHONE NO : 61 7 38411188 
95 BRANDL STREET                  SE DECISION MADE: 27-JAN-16
EIGHT MILE PLAINS  AU 4113        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology
Surgical Instrument Services and S510(k) NO: K151405(Traditional)
ATTN: Brandi  Panteleon           PHONE NO : 541 9233310 
2747 SW 6th St.                   SE DECISION MADE: 26-JAN-16
Redmond OR  97756                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+
SCANDIDOS AB                      510(k) NO: K151426(Traditional)
ATTN: THOMAS  MATZEN              PHONE NO : 46 18 4723030 
DAG HAMMARSKJOLDS VAG 52A         SE DECISION MADE: 29-JAN-16
UPPSALA  SE SE-75237              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PICO Single Use Negative Pressure Wound Therapy System
SMITH & NEPHEW MEDICAL LTD        510(k) NO: K151436(Traditional)
ATTN: SAMANTHA  NEILSON           PHONE NO : 44 1482 673790 
101 HESSLE ROAD                   SE DECISION MADE: 28-JAN-16
HULL  GB HU3 2BN                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoscope Sterilization Tray
INTUITIVE SURGICAL, INC.          510(k) NO: K151450(Traditional)
ATTN: Kunal  Gunjal               PHONE NO : 408 5238017 
1266 KIFER ROAD                   SE DECISION MADE: 12-JAN-16
SUNNYVALE CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIX Wrist System
Jeil Medical Corporation          510(k) NO: K151468(Traditional)
ATTN: Jiwon  Kang                 PHONE NO : 82 2 8503524 
702, 703, 704, 705, 706, 804, 805,SE DECISION MADE: 14-JAN-16
Seoul-City  KR 152-728            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE,  Diatron Glucose Hexokinase Method
Diatron US, Inc.                  510(k) NO: K151487(Traditional)
ATTN: Frank  Matusazak            PHONE NO : 877 6841139 
2304 W 78th Street                SE DECISION MADE: 14-JAN-16
Hialeah FL  33016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Falck Medical Multifunction Tonometer, FAT1
FALCK MEDICAL, INC                510(k) NO: K151491(Traditional)
ATTN: FRANCIS  FALCK              PHONE NO : 860 5369000 
35 WASHINGTON STREET              SE DECISION MADE: 15-JAN-16
MYSTIC CT  06355                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ROSA Spine
MEDTECH S.A.                      510(k) NO: K151511(Traditional)
ATTN: MICHAEL  CHRIST             PHONE NO : 33 04 67107740 
ZAC EUREKA - 900 RUE DU MAS DE VERSE DECISION MADE: 04-JAN-16
MONTPELLIER  FR 34000             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System
NEUROTHERAPIES RESET GMBH.        510(k) NO: K151558(Traditional)
ATTN: MICHAEL PELHAM MORRIS  OLIVEPHONE NO : 44 207 3839889 
KARL-HEINZ-BECKHURTS-SRT.13       SE DECISION MADE: 20-JAN-16
JUELICH  DE D-52428               510(k) STATEMENT
                                                    

DEVICE: Carestation 620/650/650C
DATEX-OHMEDA, INC.                510(k) NO: K151570(Traditional)
ATTN: JAMES  RASKOB               PHONE NO : 608 7093581 
3030 OHMEDA DR. P.O. BOX 7550     SE DECISION MADE: 21-JAN-16
MADISON WI  53707-7550            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ellipse Supplemental Instrument Trays
Ellipse Technologies, Incorporated510(k) NO: K151594(Abbreviated)
ATTN: Cora  Sim                   PHONE NO : 949 8373600 
13900 Alton Parkway, Suite 123    SE DECISION MADE: 25-JAN-16
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Livewire Electrophysiology Catheter 
SURGICAL INSTRUMENT SERVICE AND SA510(k) NO: K151617(Traditional)
ATTN: BRANDI  J. PANTELEON        PHONE NO : 541 9233310 
2747 SW 6TH ST.                   SE DECISION MADE: 22-JAN-16
REDMOND OR  97756                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Firefly Peritoneal Dialysis Connector Disinfection System
PURACATH MEDICAL, INC.            510(k) NO: K151620(Traditional)
ATTN: JOHN  ASHLEY                PHONE NO : 650 3024380 
660 4TH STREET #104               SE DECISION MADE: 20-JAN-16
SAN FRANCISCO CA  94107           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioHorizons CAD/CAM Abutments
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K151621(Traditional)
ATTN: MICHAEL   DAVIS             PHONE NO : 205 9677880 
2300 RIVERCHASE CENTER            SE DECISION MADE: 13-JAN-16
BIRMINGHAM AL  35244              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Renovo Life Hard Carbon Coated Drill Bit
Renovo Life LLC                   510(k) NO: K151661(Traditional)
ATTN: Harold  Crowder             PHONE NO : 704 2244136 
1104 Spruce Street                SE DECISION MADE: 15-JAN-16
Belmont NC  28012                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iRestore
Freedom Laser Therapy, Inc.       510(k) NO: K151662(Traditional)
ATTN: Craig  Nabat                PHONE NO : 323 9330304 
7815 Beverly Blvd., 3rd Floor     SE DECISION MADE: 06-JAN-16
Los Angeles CA  90036             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tenodesis screw system
NORMED MEDIZIN-TECHNIK GMBH       510(k) NO: K151701(Traditional)
ATTN: ARNE  BRIEST                PHONE NO : 49 7461 93430 
ULRICHSTRASSE 7                   SE DECISION MADE: 26-JAN-16
TUTTLINGEN  DE D-78532            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cable-Ready Cable Grip System: Cable-Ready Bone Plate System
ZIMMER, INC.                      510(k) NO: K151716(Traditional)
ATTN: Patrick  McCullagh          PHONE NO : 574 3724656 
P.O. BOX 708                      SE DECISION MADE: 28-JAN-16
WARSAW IN  46580                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
ADVANCED STERILIZATION PRODUCTS   510(k) NO: K151725(Traditional)
ATTN: SUN  CHOI                   PHONE NO : 949 4536378 
33 TECHNOLOGY DRIVE               SE DECISION MADE: 13-JAN-16
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AVS AL and AVS ALign PEEK Spacers, AVS PL  and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer
Stryker Corporation               510(k) NO: K151726(Traditional)
ATTN: Garry T Hayeck              PHONE NO : 201 7608043 
2 Pearl Court                     SE DECISION MADE: 20-JAN-16
Allendale NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TriMed Humeral Supracondylar Fixation System
TriMed, Inc.                      510(k) NO: K151735(Traditional)
ATTN: Michael  Capellan           PHONE NO : 661 2557406 
27533 Avenue Hopkins              SE DECISION MADE: 29-JAN-16
Santa Clarita CA  91355           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
IMMUNALYSIS CORPORATION           510(k) NO: K151771(Traditional)
ATTN: JOSEPH  GINETE              PHONE NO : 1 909 4820840 
829 TOWNE CENTER DR               SE DECISION MADE: 05-JAN-16
POMONA CA  91767                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Holter System
EDAN INSTRUMENTS, INC.            510(k) NO: K151787(Traditional)
ATTN: QUEENA  CHEN                PHONE NO : 86 755 26858736 
3/F - B, NANSHAN MEDICAL EQUIPMENTSE DECISION MADE: 27-JAN-16
SHENZHEN  CN 518067               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci Xi Surgical System
Intuitive Surgical, Inc.          510(k) NO: K151794(Traditional)
ATTN: Brandon  Hansen             PHONE NO : 408 5232100 
1266 Kifer Road                   SE DECISION MADE: 15-JAN-16
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PATIENT MONITORS VARIOUS MODELS
PHILIPS MEDICAL SYSTEMS           510(k) NO: K151812(Traditional)
ATTN: MARY   KRUITWAGEN           PHONE NO : 978 6594932 
3000 MINUTEMAN ROAD               SE DECISION MADE: 26-JAN-16
ANDOVER MA  03104-1099            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rainbow Shine
GENOSS                            510(k) NO: K151842(Traditional)
ATTN: BYUNGSUN  KIM               PHONE NO : 82 31 8885100 
105 GWANGGYO-RO, YEONGTONG-GU     SE DECISION MADE: 14-JAN-16
SUWON-SI  KR 443-270              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rainbow LS Pressing
GENOSS                            510(k) NO: K151846(Traditional)
ATTN: BYUNGSUN  KIM               PHONE NO : 82 31 8885100 
1F, GYEONGGI R&DB CENTER / 226, 2FSE DECISION MADE: 14-JAN-16
SUWON-SI  KR 443-270              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System
ZIMMER, INC.                      510(k) NO: K151848(Traditional)
ATTN: PATRICK  MCCULLAGH          PHONE NO : 574 3724656 
P.O. BOX 708                      SE DECISION MADE: 15-JAN-16
WARSAW IN  46580                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: K-Y Marilyn Pleasure Gel
Reckitt Benckiser LLC             510(k) NO: K151884(Traditional)
ATTN: ELIZABETH  TORRE            PHONE NO : 1 973 4042715 
399 Interpace Parkway             SE DECISION MADE: 11-JAN-16
Parsippany NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COALITION Spacers
GLOBUS MEDICAL INC.               510(k) NO: K151939(Traditional)
ATTN: KELLY J. BAKER              PHONE NO : 610 9301800 1670
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 29-JAN-16
AUDUBON PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AirLife Infant Single Limb Heated Wire Circuit
CAREFUSION INC                    510(k) NO: K151959(Traditional)
ATTN: ERIKA  FERNANDEZ            PHONE NO : 847 3628097 
75 N FAIRWAY DRIVE                SE DECISION MADE: 20-JAN-16
VERNON HILLS IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile High-pressure Angiographic Syringes for Single-use
SHENZHEN BAOAN MEDICAL SUPPLIES CO510(k) NO: K151960(Traditional)
ATTN: MINGAN  MU                  PHONE NO : 86 755 28638515 
INDUSTRIAL ZONE, SHENKENG, LIUYUE SE DECISION MADE: 07-JAN-16
SHENZHEN  CN 518173               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hospira Extension Sets
Hospira, Inc.                     510(k) NO: K151969(Traditional)
ATTN: Charles  Neitzel            PHONE NO : 224 2126087 
375 Field Drive                   SE DECISION MADE: 19-JAN-16
Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TAURUS C1
SHINHUNG COMPANY LTD              510(k) NO: K151996(Traditional)
ATTN: SKY  SHIN                   PHONE NO : 82 2 63662124 
SHINHUNG BLDG, 450 CHEONGPA-RO, JUSE DECISION MADE: 22-JAN-16
SEOUL  KR 100-858                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Evogue Dental Unit
TAKARA BELMONT CORPORATION        510(k) NO: K152100(Traditional)
ATTN: Toshinori  Kiyomatsu        PHONE NO : 81 66213 5945 
1-1-2 CHOME, HIGASHI-SHINSAIBASHI,SE DECISION MADE: 22-JAN-16
OSAKA  JP 542-0083                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Vessel Sealer
STERILMED, INC.                   510(k) NO: K152134(Traditional)
ATTN: PATRICIA   KAUFMAN          PHONE NO : 763 4883211 
5010 Cheshire Pkwy Ste 2          SE DECISION MADE: 15-JAN-16
Plymouth MN  55446                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FacetBRIDGE System
LDR SPINE USA                     510(k) NO: K152137(Traditional)
ATTN: James  Wilson               PHONE NO : 512 3443333 
13785 Research Boulevard, Suite 20SE DECISION MADE: 25-JAN-16
Austin TX  78750                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VersaOne Bladed Trocar 5mm
COVIDIEN                          510(k) NO: K152149(Special)
ATTN: Trang  Huynh                PHONE NO : 203 4927473 
60 Middletown Avenue              SE DECISION MADE: 22-JAN-16
North Haven CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QUAD Dental Implants and Prostheses
Dentack Impants Ltd               510(k) NO: K152188(Traditional)
ATTN: David  Salton               PHONE NO : 972 9 7660379 
24 Ha Ta'as St                    SE DECISION MADE: 28-JAN-16
Kfar-Saba, POB 2405  IL 4464102   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR 
DENTALPLUS GMBH                   510(k) NO: K152215(Traditional)
ATTN: RALF GERSCHUETZ RUETH       PHONE NO : 49 8032 9892007 
KOHLGRUB 5                        SE DECISION MADE: 19-JAN-16
SAMERBERG   DE 83122              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
Sportarredo Group S.C.            510(k) NO: K152233(Traditional)
ATTN: Stefano  Iridio             PHONE NO : 0039 0421 767676 
Via dell' Industria 7             SE DECISION MADE: 27-JAN-16
Gruaro  IT 30020                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medtronic Transportation/Sterilization Cassettes
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K152241(Traditional)
ATTN: Victoria  Scheitlin         PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 20-JAN-16
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ONLINE TDM Vancomycin Gen.3
ROCHE DIAGNOSTICS OPERATIONS (RDO)510(k) NO: K152245(Traditional)
ATTN: BARBARA  MCWHORTER          PHONE NO : 317 5212336 
9115 HAGUE ROAD                   SE DECISION MADE: 08-JAN-16
INDIANAPOLIS IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ATLANTIS Crown
DENTSPLY INTERNATIONAL, INC.      510(k) NO: K152247(Traditional)
ATTN: HELEN  LEWIS                PHONE NO : 717 4871332 
221 WEST PHILADELPHIA ST. SUITE 60SE DECISION MADE: 29-JAN-16
YORK PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pentacam AXL
OCULUS OPTIKGERATE GMBH           510(k) NO: K152311(Traditional)
ATTN: ECKHARD  LOH                PHONE NO : 49 641 20050 
MUNCHHOLZHAUSER STRASE 29         SE DECISION MADE: 20-JAN-16
WETZLA  DE 35582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline ReNewal Reprocessed Endopath Endoscopic Instruments
Surgical Instrument Services and S510(k) NO: K152313(Traditional)
ATTN: Brandi J Panteleon          PHONE NO : 541 9233310 
2747 SW 6th St.                   SE DECISION MADE: 06-JAN-16
Redmond OR  97756                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Total Bilirubin
RANDOX LABORATORIES LIMITED       510(k) NO: K152344(Traditional)
ATTN: PAULINE  ARMSTRONG          PHONE NO : 44 0 2894422413 2275
55 DIAMOND ROAD,ARDMORE           SE DECISION MADE: 28-JAN-16
CRUMLIN, COUNTY ANTRIM  GB BT29 4Q510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stereo 3D option for Vision Applications
GE MEDICAL SYSTEMS, SCS           510(k) NO: K152352(Traditional)
ATTN: NING  WEN                   PHONE NO : 33 1 30705668 
283 RUE DE LA MINIERE             SE DECISION MADE: 20-JAN-16
BUC  FR 78530                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sapphire
RESPIRONICS INC.                  510(k) NO: K152356(Traditional)
ATTN: COLLEEN  WITT               PHONE NO : 724 387 4146
1001 MURRY RIDGE LANE             SE DECISION MADE: 08-JAN-16
MURRYSVILLE PA  15668             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System
Liebel-Flarsheim Company LLC      510(k) NO: K152361(Traditional)
ATTN: Craig  Buehler              PHONE NO : 314 6543188 
2111 East Galbraith Rd            SE DECISION MADE: 14-JAN-16
Cincinnati OH  45237              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LL TENS 160A, LL TENS 160B
Fuji Dynamics Ltd                 510(k) NO: K152374(Traditional)
ATTN: Man Man Chung               PHONE NO : 852 27864218 
1-3, 23/F., Laws Commercial Plaza,SE DECISION MADE: 13-JAN-16
Hong Kong  CN                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VINTAGE LD
SHOFU DENTAL CORPORATION          510(k) NO: K152392(Traditional)
ATTN: Mauro  Malzyner             PHONE NO : 760 7363277 
1225 STONE DRIVE                  SE DECISION MADE: 08-JAN-16
SAN MARCOS CA  92078              510(k) STATEMENT
                                                    

DEVICE: General & Plastic Surgery Instruments
Sontec Instruments Inc.           510(k) NO: K152400(Traditional)
ATTN: Stefan M. Scanlan           PHONE NO : 303 7909411 
7248 South Tucson Way             SE DECISION MADE: 22-JAN-16
Centennial CO  80112              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASAHI Caravel
ASAHI INTECC CO., LTD.            510(k) NO: K152447(Traditional)
ATTN: YOSHIHIKO  FUKUI            PHONE NO : 81 52 7681211 
1703 WAKITA-CHO, MORIYAMA-KU      SE DECISION MADE: 22-JAN-16
NAGOYA  JP 463-0024               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Esophageal Cooling Device
ADVANCED COOLING THERAPY, LLC     510(k) NO: K152450(Traditional)
ATTN: Erik  Kulstad               PHONE NO : 312 7254756 
3440 S Dearborn St.  # 215-South  SE DECISION MADE: 15-JAN-16
Chicago IL  60616                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CenterCross Ultra Catheter
ROXWOOD MEDICAL, INC.             510(k) NO: K152456(Traditional)
ATTN: Grace  Li                   PHONE NO : 650 7796559 
400 SEAPORT CT, SUITE #103        SE DECISION MADE: 26-JAN-16
REDWOOD CITY CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant
PORIFEROUS LLC                    510(k) NO: K152463(Traditional)
ATTN: JERRI L. MANN               PHONE NO : 877 6311954 
535 PINE ROAD, SUITE 206          SE DECISION MADE: 20-JAN-16
NEWNAN GA  30263-7640             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAS-One IR
CAScination AG                    510(k) NO: K152473(Traditional)
ATTN: Matthias  Peterehans        PHONE NO : 41 315 520440 
Steigerhubelstrasse 3             SE DECISION MADE: 20-JAN-16
Bern  CH 3008                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORZA PTC Spacer System
ORTHOFIX INC.                     510(k) NO: K152475(Traditional)
ATTN: NATALIA  VOLOSEN            PHONE NO : 214 9372145 
3451 PLANO PARKWAY                SE DECISION MADE: 14-JAN-16
LEWISVILLE TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PW Guidewires
TATARA VASCULAR, LLC.             510(k) NO: K152497(Traditional)
ATTN: KELLY  EMERTON              PHONE NO : 216 4449773 
10000 CEDAR AVE                   SE DECISION MADE: 22-JAN-16
CLEVELAND OH  44106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SoloPath Re-Collapsible Access System
ONSET MEDICAL CORPORATION         510(k) NO: K152498(Traditional)
ATTN: Monika  McDole-Russell      PHONE NO : 732 3024900 4273
13900 ALTON PARKWAY, SUITE 120    SE DECISION MADE: 05-JAN-16
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImagenSPECT
CARDIOVASCULAR IMAGING TECHNOLOGIE510(k) NO: K152503(Traditional)
ATTN: JAMES  CASE                 PHONE NO : 816 5312842 
4320 WORNALL ROAD, SUITE 114      SE DECISION MADE: 25-JAN-16
KANSAS CITY MO  64111             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)
ALTATEC GMBH                      510(k) NO: K152509(Traditional)
ATTN: COLLEEN   BOSWELL           PHONE NO : 49 7044 94450 
MAYBACHSTRASSE 5                  SE DECISION MADE: 12-JAN-16
WIMSHEIM  DE D-71299              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Half Dome Posterior Lumbar Interbody System
Astura Medical                    510(k) NO: K152512(Traditional)
ATTN: Thomas  Astura              PHONE NO : 760 8148047 
5670 El Camino Real, Suite B      SE DECISION MADE: 28-JAN-16
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Magicore System
INNOBIOSURG CO., LTD              510(k) NO: K152520(Traditional)
ATTN: BO-REUM   YOO               PHONE NO : 82 42 9332879 
44-19, Techno 10-ro, Yuseong-gu   SE DECISION MADE: 25-JAN-16
Daejeon   KR 305-510              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes
ECOLAB, INC.                      510(k) NO: K152522(Special)
ATTN: Jennifer  Willner           PHONE NO : 651 2504348 
370 WABASHA STREET NORTH          SE DECISION MADE: 15-JAN-16
SAINT PAUL MN  55102              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InstaClear Lens Cleaner
GYRUS ACMI, INC.                  510(k) NO: K152531(Traditional)
ATTN: DOLAN  MILLS                PHONE NO : 901 3730236 
136 TURNPIKE ROAD                 SE DECISION MADE: 15-JAN-16
SOUTHBOROUGH MA  01772            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyOn HC Manual Wheelchair
INVACARE CORPORATION              510(k) NO: K152536(Traditional)
ATTN: Elijah N. Wreh              PHONE NO : 440 3296840 
ONE INVACARE WAY                  SE DECISION MADE: 05-JAN-16
ELYRIA OH  44035                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Penumbra System ACE 64 and ACE 68 Reperfusion Catheters
PENUMBRA, INC.                    510(k) NO: K152541(Traditional)
ATTN: MICHAELA  MAHL              PHONE NO : 510 7483288 
ONE PENUMBRA PLACE                SE DECISION MADE: 13-JAN-16
ALAMEDA CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stroke VCAR
GE MEDICAL SYSTEMS SCS            510(k) NO: K152584(Traditional)
ATTN: Peter  Uhlir                PHONE NO : 36 147 93318 
283 RUE DE LA MINIERE             SE DECISION MADE: 20-JAN-16
BUC  FR 78530                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bio2 CLM BG Bioactive Scaffold
Bio2 Technologies, Inc            510(k) NO: K152589(Traditional)
ATTN: Janet  Krevolin             PHONE NO : 781 5690559 
12 R Cabot Road                   SE DECISION MADE: 12-JAN-16
Woburn MA  01801                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set
Medtronic Sofamor Danek USA, Incor510(k) NO: K152604(Traditional)
ATTN: Pamela  Edwards             PHONE NO : 901 3440807 
1800 Pyramid Place                SE DECISION MADE: 06-JAN-16
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: True Flow Valvuloplasty Perfusion Catheter
C. R. BARD, INC.                  510(k) NO: K152613(Traditional)
ATTN: AARON  CONOVALOFF           PHONE NO : 480 3506012 
1625 WEST 3RD STREET              SE DECISION MADE: 19-JAN-16
TEMPE AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spine Wave Gen II Expandable Interbody System
SPINE WAVE, INC.                  510(k) NO: K152620(Traditional)
ATTN: Gail  Yaeker-Daunis         PHONE NO : 203 9449494 
3 ENTERPRISE DRIVE, SUITE 210     SE DECISION MADE: 15-JAN-16
SHELTON CT  06484                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IFS Fixation Scaffold System
METRIC MEDICAL DEVICES, INC.      510(k) NO: K152627(Traditional)
ATTN: W.Casey  Fox                PHONE NO : 830 5356300 
846 SILVER SPRINGS                SE DECISION MADE: 13-JAN-16
HELOTES TX  78023                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)
PMS TIP TEKNOLOJILERI SANAYI VE TI510(k) NO: K152669(Traditional)
ATTN: DERYA  DIKICI               PHONE NO : 90 324 2387042 
MERSIN TARSUS ORGANIZE SANAYI BOLGSE DECISION MADE: 15-JAN-16
MERSIN  TR 33020                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables
Medos International SARL          510(k) NO: K152670(Traditional)
ATTN: Elena  Jugo                 PHONE NO : 305 2656802 
Chemin-Blanc 38                   SE DECISION MADE: 22-JAN-16
Le Locle  CH CH-2400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cajun Commando 4x4
LIL CRITTER, LLC                  510(k) NO: K152672(Traditional)
ATTN: BRENDA  BRANT               PHONE NO : 318 3665772 
2701 OLIVER ROAD                  SE DECISION MADE: 21-JAN-16
MONROE LA  71201                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FD TENS 2090, FD TENS 2095 
FUJI DYNAMICS LTD                 510(k) NO: K152676(Traditional)
ATTN: MAN CHUNG MAN               PHONE NO : 852 2786 4218 
 1-3, 23/F., LAWS COMMERICAL PLAZASE DECISION MADE: 22-JAN-16
HONG KONG  CN                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nerve Capping Device
POLYGANICS INNOVATIONS BV         510(k) NO: K152684(Traditional)
ATTN: BETTY  IJMKER               PHONE NO : 31 50 5886598 
ROZENBURGLAAN 15A                 SE DECISION MADE: 13-JAN-16
GRONINGEN  NL 9727 DL             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DISPOSABLE THERMOMETER PROBE SHEATHS
PINGHU SAMA MEDICAL PACKING CO., L510(k) NO: K152690(Traditional)
ATTN: MA  JIANZHONG               PHONE NO : 86 573 85923333 
1 QUNFENG ROAD SOUTH OF LINDAI    SE DECISION MADE: 15-JAN-16
PINGHU  CN 314202                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INFX-8000V, V6.20
Toshiba Medical Systems Corporatio510(k) NO: K152696(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 12-JAN-16
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INFX-8000C, V6.20 
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K152697(Traditional)
ATTN: JANINE  REYES               PHONE NO : 714 6697808 
1385 SHIMOISHIGAMI                SE DECISION MADE: 15-JAN-16
OTAWARA-SHI  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FFRct
HEARTFLOW, INC.                   510(k) NO: K152733(Traditional)
ATTN: WINDI  HARY                 PHONE NO : 650 2411250 
1400 SEAPORT BOULEVARD, BUILDING BSE DECISION MADE: 13-JAN-16
REDWOOD CITY CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mepiseal Soft Silicone Sealant
MOLNLYCKE HEALTH CARE, US LLC     510(k) NO: K152741(Traditional)
ATTN: MEGAN  BEVILL               PHONE NO : 470 3750049 
5550 PEACHTREE PARKWAY SUITE 500  SE DECISION MADE: 22-JAN-16
NORCROSS GA  30092                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ez3D Plus
EWOO SOFT CO., LTD.               510(k) NO: K152746(Traditional)
ATTN: YOUNG SEOK KIM              PHONE NO : 82 31 80156171 
401-1-HO, 13, SAMSUNG 1-RO 2-GIL  SE DECISION MADE: 03-JAN-16
HWASEONG-SI  KR 18449             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bovie Disposable Bipolar Ablator
BOVIE MEDICAL CORPORATION         510(k) NO: K152777(Traditional)
ATTN: BRIAN  KUNST                PHONE NO : 727 8038617 
5115 ULMERTON ROAD                SE DECISION MADE: 15-JAN-16
CLEARWATER FL  33760              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venus Versa System
VENUS CONCEPT LTD.                510(k) NO: K152790(Traditional)
ATTN: TAL  BRESLER-STRAMER        PHONE NO : 416 9070115 
4556 N. HIATUS ROAD               SE DECISION MADE: 20-JAN-16
SUNRISE FL  33351                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unison-C Anterior Cervical Fixation System 
PIONEER SURGICAL TECHNOLOGY,INC. D510(k) NO: K152793(Traditional)
ATTN: EMILY  ROBERGE              PHONE NO : 906 2255602 
375 RIVER PARK CIRCLE             SE DECISION MADE: 19-JAN-16
MARQUETTE MI  49855               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Grasping Forceps
MICRO-TECH (NANJING) CO., LTD.    510(k) NO: K152802(Traditional)
ATTN: BECKY  LI                   PHONE NO : 86 25 58646378 
NO. 10 GAOKE THIRD ROAD           SE DECISION MADE: 21-JAN-16
NANJING  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DeVilbiss DV6WM Wireless Modem
DeVilbiss Healthcare, LLC         510(k) NO: K152810(Traditional)
ATTN: Betty  Miller               PHONE NO : 814 4437602 
100 DeVilbiss Drive               SE DECISION MADE: 21-JAN-16
Somerset PA  15501                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ponto Bone Anchored Hearing System
OTICON MEDICAL AB                 510(k) NO: K152820(Traditional)
ATTN: CAROLINA ANKER WESSLING     PHONE NO : 46 31 7486100 
DATAVAGEN 37B                     SE DECISION MADE: 22-JAN-16
ASKIM  SE 436 32                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pruitt F3-S Polyurethane Carotid Shunt
LEMAITRE VASCULAR, INC.           510(k) NO: K152833(Traditional)
ATTN: ANNA  KASSERIS              PHONE NO : 781 4251706 
63 SECOND AVENUE                  SE DECISION MADE: 21-JAN-16
BURLINGTON MA  01803              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: S50 Digital Color Doppler Ultrasound System
SONOSCAPE MEDICAL CORP.           510(k) NO: K152854(Traditional)
ATTN: Toki  Wu                    PHONE NO : 86 755 26722890 
4/f, 5/f, 8/f, 9/f & 10/f, yizhe bSE DECISION MADE: 13-JAN-16
Shenzhen  CN 518051               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LipiView II Ocular Surface Interferometer
TEARSCIENCE, INC.                 510(k) NO: K152869(Traditional)
ATTN: CHRISTY  COLEMAN            PHONE NO : 919 4594815 
5151 MCCRIMMON PKWY., STE 250     SE DECISION MADE: 14-JAN-16
MORRISVILLE NC  27650             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: K2M Fenestrated Tap System
K2M                               510(k) NO: K152872(Traditional)
ATTN: NANCY  GIEZEN               PHONE NO : 571 9192000 
751 MILLER DRIVE SE               SE DECISION MADE: 05-JAN-16
LEESBURG VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Crosstella RX Balloon Dilatation Catheter
KANEKA CORPORATION                510(k) NO: K152873(Traditional)
ATTN: TOSHIHIKO  MOTOMINE         PHONE NO : 81 3 55748023 
1-12-32, AKASAKA, MINATO-KU       SE DECISION MADE: 22-JAN-16
TOKYO  JP 107-6025                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM
TNI Manufacturing, Inc.           510(k) NO: K152876(Traditional)
ATTN: DANIEL  SABLYAK             PHONE NO : 954 4725988 
4635 NW 103rd Avenue              SE DECISION MADE: 08-JAN-16
Sunrise FL  33351                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biograph Horizon PET/CT
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K152880(Traditional)
ATTN: ALAINE  MEDIO               PHONE NO : 865 2182703 
810 INNOVATION DRIVE              SE DECISION MADE: 12-JAN-16
KNOXVILLE TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Crosperio RX PTA Balloon Dilatation Catheter
Kaneka Corporation                510(k) NO: K152887(Traditional)
ATTN: Toshihiko  Motomine         PHONE NO : 81 3 55748023 
1-12-32, Akasaka, Minato-ku       SE DECISION MADE: 22-JAN-16
Tokyo  JP 107-6025                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EYE-SYNC
SyncThink, Inc.                   510(k) NO: K152915(Traditional)
ATTN: Daniel  Beeler              PHONE NO : 1 603 5689447 
54 Canal Street Suite 200         SE DECISION MADE: 29-JAN-16
Boston MA  02114                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TIVA¿
VELANO VASCULAR                   510(k) NO: K152924(Traditional)
ATTN: TIFFINI  DIAGE              PHONE NO : 707 7996732 
4040 LOCUST ST                    SE DECISION MADE: 07-JAN-16
PHILADELPHIA PA  19104            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AQUACEL Ag Surgical SP Dressing
CONVATEC LIMITED                  510(k) NO: K152926(Special)
ATTN: AARON  SIBLEY               PHONE NO : 44 0 1494816054 
FIRST AVENUE, DEESIDE INDUSTRIAL PSE DECISION MADE: 21-JAN-16
DEESIDE  GB CH5 2NU               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasiveNVM5 System
NUVASIVE INCORPORATED             510(k) NO: K152942(Traditional)
ATTN: Olga  Lewis                 PHONE NO : 858 3205257 
7475 LUSK BOULEVARD               SE DECISION MADE: 13-JAN-16
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems
MORTARA INSTRUMENT, INC.          510(k) NO: K152944(Traditional)
ATTN: ELEANORE  DIAS              PHONE NO : 414 3541600 
7865 NORTH 86TH STREET            SE DECISION MADE: 06-JAN-16
MILWAUKEE WI  53224               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quell
NEUROMETRIX, INC.                 510(k) NO: K152954(Traditional)
ATTN: RAINER  MAAS                PHONE NO : 781 3142781 
1000 WINTER STREET                SE DECISION MADE: 05-JAN-16
WALTHAM MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aequalis Fx2 
Tornier SAS                       510(k) NO: K152966(Special)
ATTN: JOVILA  DODI                PHONE NO : 33 04 76613500 
161 RUE LAVOISIER                 SE DECISION MADE: 14-JAN-16
MONTBONNOT SAINT MARTIN  FR 38330 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Amendia Stand-Alone Cervical System
AMENDIA, INC.                     510(k) NO: K152972(Traditional)
ATTN: KRISTEN   ALLEN             PHONE NO : 877 7553329 
1755 WEST OAK PARKWAY             SE DECISION MADE: 14-JAN-16
MARIETTA GA  30062                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DG PACS
DICOM GRID, INC.                  510(k) NO: K152977(Traditional)
ATTN: LAUREN  STILL               PHONE NO : 888 5872280 
4530 E MUIRWOOD DRIVE, SUITE 113  SE DECISION MADE: 25-JAN-16
PHOENIX AZ  85048                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flo Trac sensor, Volume View sensor
Edwards Lifesciences, LLC         510(k) NO: K152980(Traditional)
ATTN: Andrew S Mazurkiewicz       PHONE NO : 949 2505167 
One Edwards Way                   SE DECISION MADE: 19-JAN-16
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StatStrip Xpress 2 Glucose Hospital Meter System
NOVA BIOMEDICAL CORPORATION       510(k) NO: K152986(Special)
ATTN: PAUL W. MACDONALD           PHONE NO : 781 8940800 211
200 PROSPECT STREET               SE DECISION MADE: 27-JAN-16
WALTHAM MA  02454                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MUSE Cardiology Information System
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K152993(Special)
ATTN: AMY  YANG                   PHONE NO : 414 7213807 
9900 WEST INNOVATION DRIVE        SE DECISION MADE: 12-JAN-16
WAUWATOSA WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sofia Influenza A+B FIA
QUIDEL CORPORATION                510(k) NO: K153012(Traditional)
ATTN: EDWARD C. BREHM             PHONE NO : 858 5521100 1015
12544 HIGH BLUFF DRIVE, SUITE 200 SE DECISION MADE: 12-JAN-16
SAN DIEGO CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Turbett Surgical Container
TURBETT SURGICAL LLC              510(k) NO: K153025(Traditional)
ATTN: ROB  TURBETT                PHONE NO : 585 7550133 
125 TECH PARK DRIVE SUITE 2108    SE DECISION MADE: 14-JAN-16
ROCHESTER NY  14623               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: aap LOQTEQ VA Radius Set 2.5
AAP IMPLANTATE AG                 510(k) NO: K153034(Traditional)
ATTN: Christian  Zietsch          PHONE NO : 0049 30 75019193 
LORENZWEG 5                       SE DECISION MADE: 21-JAN-16
BERLIN  DE D-12099                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOGIQ V1/ LOGIQ V2
GE MEDICAL SYSTEMS ULTRASOUND & PR510(k) NO: K153037(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 414 6766120 
9900 W. INNOVATION DRIVE          SE DECISION MADE: 04-JAN-16
WAUWATOSA WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MRI Dynamic Analysis Plus
Esaote S.p.A.                     510(k) NO: K153039(Special)
ATTN: DONATELLA  RAGGHIANTI       PHONE NO : 011 39 0106547259 
Via Siffredi 58                   SE DECISION MADE: 08-JAN-16
Genovo  IT 16153                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Erchonia PL Touch
ERCHONIA CORPORATION              510(k) NO: K153052(Special)
ATTN: Steven  Shanks              PHONE NO : 214 5442227 
2021 COMMERCE DR                  SE DECISION MADE: 04-JAN-16
MCKINNEY TX  75069                510(k) STATEMENT
                                                    

DEVICE: Edwards Balloon Catheter
EDWARDS LIFESCIENCES              510(k) NO: K153069(Traditional)
ATTN: CHRIS  KENNELLY             PHONE NO : 949 2502019 
1 EDWARDS WAY                     SE DECISION MADE: 07-JAN-16
IRVINE CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IntraNovo Microcatheter
Texas Medical Technologies, Inc.  510(k) NO: K153125(Special)
ATTN: Aaron  Chiu                 PHONE NO : 915 7744321 
9005 Montana Ave., Suite A        SE DECISION MADE: 13-JAN-16
El Paso TX  79925                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: dynaMX Tabbed Staple
MX Orthopedics, Corp.             510(k) NO: K153129(Traditional)
ATTN: Howard L. Schrayer          PHONE NO : 617 5773951 
1 Broadway, 14th Floor            SE DECISION MADE: 28-JAN-16
Cambridge MA  02142               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cios Connect
Siemens Medical Solutions USA, Inc510(k) NO: K153147(Traditional)
ATTN: Patricia D. Jones           PHONE NO : 610 4486474 
40 Liberty Boulevard, 65-1A       SE DECISION MADE: 12-JAN-16
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sonendo Gentle Wave System
SONENDO, INC.                     510(k) NO: K153157(Special)
ATTN: DAN W. MILLER               PHONE NO : 949 7663636 
26061 MERIT CIRCLE, SUITE 102     SE DECISION MADE: 29-JAN-16
LAGUNA HILLS CA  92653            510(k) STATEMENT
                                                    

DEVICE: Vinyl patient examination glove, Powder Free
XINGYUAN PLASTIC PRODUCTS CO., LTD510(k) NO: K153159(Traditional)
ATTN: QIWEI  XING                 PHONE NO : 86 0315 4167693 
#100, CHANGDA ROAD, SIGEZHUANG, LUSE DECISION MADE: 26-JAN-16
TANGSHAN  CN 063503               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fusion Bx
FOCAL HEALTCARE INC.              510(k) NO: K153166(Third Party - Traditional)
ATTN: MAHAM  ANSARI               PHONE NO : 1 647 4799603 
10 MORROW AVE., UNIT 101          SE DECISION MADE: 25-JAN-16
TORONTO  CA M6R 2J1               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PASS OCT Patient Specific Rods
MEDICREA INTERNATIONAL            510(k) NO: K153169(Traditional)
ATTN: Davis  Ryan                 PHONE NO : 0033 47201 8787 
14 Porte du Grand Lyon            SE DECISION MADE: 29-JAN-16
NEYRON  FR 01700                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE:  Adjustable Fixation Device
ARTHROCARE CORP.                  510(k) NO: K153186(Traditional)
ATTN: Katherine  Marcaccio        PHONE NO : 508 2613602 
15285 ALTON PARKWAY, NO. 200      SE DECISION MADE: 28-JAN-16
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zenysis Short-Term Dialysis Catheter
C.R BARD INC.                     510(k) NO: K153190(Traditional)
ATTN: SILVIA   DE LA BARRA        PHONE NO : 801 5225909 
605 NORTH 5600 WEST               SE DECISION MADE: 05-JAN-16
SALT LAKE CITY UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fortress Introducer Sheath SYstem
CONTRACT MEDICAL INTERNATIONAL GMB510(k) NO: K153197(Special)
ATTN: JAN  KLOBOUCNIK             PHONE NO : 420 49 4949564 
LAUENSTEINER STRASSE 37           SE DECISION MADE: 11-JAN-16
DRESDEN  DE 01277                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Full Automatic (NIBP) Blood Pressure Monitor
HEALTH & LIFE CO., LTD.           510(k) NO: K153214(Traditional)
ATTN: SARAH  SU                   PHONE NO : 886 2 82271300 1201
9F, NO. 186, JIAN YI ROAD         SE DECISION MADE: 07-JAN-16
ZHONGHE DISTRICT, NEW TAIPEI CITY 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ConforMIS iTotal Posterior Stabilized Knee Replacement System
ConforMIS, Inc.                   510(k) NO: K153217(Traditional)
ATTN: Amita  Shah                 PHONE NO : 781 3459164 
28 Crosby Dr.                     SE DECISION MADE: 07-JAN-16
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Galaxy UNYCO System
ORTHOFIX SRL                      510(k) NO: K153233(Traditional)
ATTN: GIANLUCA  RICADONA          PHONE NO : 39 045 6719000 
VIA DELLE NAZIONI 9               SE DECISION MADE: 06-JAN-16
BUSSOLENGO   IT 37012             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Frontier Medical Devices In-Line Orthopedic Cable Cerclage System
FRONTIER MEDICAL DEVICES, INC.    510(k) NO: K153242(Traditional)
ATTN: ALLISON K. ROGERS           PHONE NO : 906 2321200 
512 FOURTH STREET                 SE DECISION MADE: 13-JAN-16
GWINN MI  49841                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VasoStat Hemostasis Device
FORGE MEDICAL, INC.               510(k) NO: K153259(Traditional)
ATTN: Timothy   Clark             PHONE NO : 215 6053225 
701 W BROAD ST, SUITE 102         SE DECISION MADE: 06-JAN-16
Bethlehem PA  18018               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated
New Deantronics Taiwan, Ltd.      510(k) NO: K153265(Traditional)
ATTN: Jane  Liu                   PHONE NO : 886 2 22681726 
12F, No. 51, Sec. 4, Chong Yang RoSE DECISION MADE: 05-JAN-16
New Taipei City  TW 23675         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEALTHMYNE 
HEALTHMYNE, INC                   510(k) NO: K153289(Third Party - Traditional)
ATTN: SIGRID  SCHOEPEL            PHONE NO : 608 8332610 
918 DEMING WAY                    SE DECISION MADE: 15-JAN-16
MADISON WI  53717                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium
WILLIAM A. COOK AUSTRALIA PTY LTD 510(k) NO: K153290(Special)
ATTN: Gordana   Pozvek            PHONE NO : 61 7 38411188 
95 BRANDL STREET                  SE DECISION MADE: 27-JAN-16
Eight Mile Plains  AU 4113        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Epic Extremity Cannulated Screw System
Epic Extremity, LLC               510(k) NO: K153333(Traditional)
ATTN: Dan  Schwartzbauer          PHONE NO : 412 9560320 
120 Marguerite Dr, Ste 301        SE DECISION MADE: 19-JAN-16
Cranberry Twp PA  16066           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VuePoint OCT System
NUVASIVE, INCORPORATED            510(k) NO: K153336(Traditional)
ATTN: Kelsey   Lien               PHONE NO : 858 9093320 
7475 LUSK BLVD.                   SE DECISION MADE: 07-JAN-16
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tiger Cannulated Screw System
Trilliant Surgical, LTD           510(k) NO: K153338(Traditional)
ATTN: Jon  Olson                  PHONE NO : 713 3886055 
6721 Portwest Dr Ste 160          SE DECISION MADE: 14-JAN-16
Houston TX  77024                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3MP Color LCD Monitor, RadiForce RX350
EIZO CORPORATION                  510(k) NO: K153354(Traditional)
ATTN: Hiroaki   Hashimoto         PHONE NO : 81 762 742468 
153 SHIMOKASHIWANO                SE DECISION MADE: 12-JAN-16
HAKUSAN  JP 924-8566              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spine Innovation Interbody System
Spine Innovation LLC              510(k) NO: K153356(Traditional)
ATTN: Jude  Paganelli             PHONE NO : 858 7747891 
 215 S. Highway 101, Suite 200    SE DECISION MADE: 14-JAN-16
Solana Beach CA  92075            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device
Medtronic Sofamor Danek           510(k) NO: K153373(Traditional)
ATTN: Sneh  Pingle                PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 19-JAN-16
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Corin Metafix Hip Stem
Corin USA Limited                 510(k) NO: K153381(Traditional)
ATTN: Rachel  King                PHONE NO : 813 9774469 
5670 W. Cypress St., Suite C      SE DECISION MADE: 21-JAN-16
Tampa FL  33607                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Perla Posterior Cervico-Thoracic Fixation system
SPINEART                          510(k) NO: K153386(Traditional)
ATTN: FRANCK  PENNESI             PHONE NO : 41 225 701246 
INTERNATIONAL CENTER COINTRIN 20 RSE DECISION MADE: 25-JAN-16
Geneva  CH 1215                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Discovery NM/CT 670 CZT
GE HEALTHCARE                     510(k) NO: K153402(Traditional)
ATTN: GEORGE  MASHOUR             PHONE NO : 972 485 63666 
4 HAYOZMA STREET                  SE DECISION MADE: 21-JAN-16
TIRAT HACARMEL  IL 30200          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Stryker External Fixation Devices
STRYKER SUSTAINABILITY SOLUTIONS  510(k) NO: K153415(Special)
ATTN: KELLI  DRYER                PHONE NO : 480 7635324 
1810 W. DRAKE DRIVE               SE DECISION MADE: 13-JAN-16
TEMPE AZ  85283                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS
HITACHI ALOKA MEDICAL AMERICA, INC510(k) NO: K153421(Traditional)
ATTN: ANGELA  VAN ARSDALE         PHONE NO : 203 2695088 
10 FAIRFIELD BLVD.                SE DECISION MADE: 21-JAN-16
WALLINGFORD CT  06492-7502        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC
ARROW INTERNATIONAL, INC. (SUBSIDI510(k) NO: K153423(Special)
ATTN: JULIE  LAWSON               PHONE NO : 610 3780131 
2400 BERNVILLE ROAD               SE DECISION MADE: 28-JAN-16
READING PA  19605                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Volpara Imaging Software
Matakina Technology LTD           510(k) NO: K153427(Traditional)
ATTN: Ralph  Highnam              PHONE NO : 064 4 4996029 
Level 12 86 Victoria Street       SE DECISION MADE: 07-JAN-16
Wellington  NZ 6011               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System
ORTHOFIX INC.                     510(k) NO: K153428(Traditional)
ATTN: Jacki  Geren                PHONE NO : 214 9372100 
3451 PLANO PARKWAY                SE DECISION MADE: 29-JAN-16
LEWISVILLE TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Direct HDL Cholesterol (HDL)
Randox Laboratories Ltd           510(k) NO: K153435(Traditional)
ATTN: Pauline  Armstrong          PHONE NO : 440 289 4422413 2275
55 Diamond Road                   SE DECISION MADE: 08-JAN-16
Ardmore Crumlin  GB BT29 4QY      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TACVAC 
ATHENA GTX                        510(k) NO: K153459(Abbreviated)
ATTN: SEAN  MAHONEY               PHONE NO : 515 2883360 103
5900 NW 86TH STREET, SUITE 300    SE DECISION MADE: 28-JAN-16
JOHNSTON IA  50131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PillCam COLON 2 Capsule Endoscopy System 
GIVEN IMAGING LTD.                510(k) NO: K153466(Traditional)
ATTN: HILLA  DEBBY                PHONE NO : 972 49097774 
2 Hacarmel St. NEW INDUSTRIAL ParkSE DECISION MADE: 14-JAN-16
Yoqneam  IL 20962                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SD5 & SD6 Ultrasonic Tabletop Doppler
EDAN INSTRUMENTS, INC.            510(k) NO: K153475(Traditional)
ATTN: QUEENA  CHEN                PHONE NO : 86 755 26858736 
3/F - B, NANSHAN MEDICAL EQUIPMENTSE DECISION MADE: 29-JAN-16
SHENZHEN  CN 518067               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip
Atricure, Inc.                    510(k) NO: K153500(Traditional)
ATTN: Jonathan  McElwee           PHONE NO : 513 6444249 
6217 Centre Park Drive            SE DECISION MADE: 27-JAN-16
West Chester OH  45069            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClariVein IC
VASCULAR INSIGHTS, LLC            510(k) NO: K153502(Special)
ATTN: LORRAINE  M. HANLEY         PHONE NO : 617 5191109 
 1 PINE HILL DRIVE, TWO BATTERYMARSE DECISION MADE: 06-JAN-16
QUINCY MA  02169                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Seneka II Polyscrew Pedicle Fixation System
Senecka Spine                     510(k) NO: K153525(Traditional)
ATTN: Khalid   Sethi              PHONE NO : 607 2374724 
46 Harrison Street                SE DECISION MADE: 28-JAN-16
Johnson City NY  13790            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Treace Medical Concepts (TMC) Plating System
TREACE MEDICAL CONCEPTS, INC.     510(k) NO: K153531(Special)
ATTN: JOE  FERGUSON               PHONE NO : 904 3735940 303
3107 SAWGRASS VILLAGE CIRCLE      SE DECISION MADE: 07-JAN-16
PONTE VEDRA BEACH FL  32082       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Piccolo Composite® Nailing System
CARBOFIX ORTHOPEDICS, LTD.        510(k) NO: K153536(Special)
ATTN: YAEL  RUBIN                 PHONE NO : 972 9 9511511 
11 HA'HOSHLIM ST.                 SE DECISION MADE: 06-JAN-16
HERZELIYA  IL 4627411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Coldplay CryoBalloon® Ablation System
C2 THERAPEUTICS, INC.             510(k) NO: K153541(Special)
ATTN: THERESA  BRANDNER-ALLEN     PHONE NO : 650 5215921 
303 CONVENTION WAY, SUITE 1       SE DECISION MADE: 07-JAN-16
REDWOOD CITY CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ebb Complete Tamponade System
CLINICAL INNOVATIONS, LLC         510(k) NO: K153591(Special)
ATTN: TOM  HAUETER                PHONE NO : 801 2688200 
747 WEST 4170 SOUTH               SE DECISION MADE: 14-JAN-16
MURRAY UT  84123                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)
MICROVENTION, INC.                510(k) NO: K153594(Special)
ATTN: Laraine  Pangelina          PHONE NO : 714 2478150 
1311 VALENCIA AVENUE              SE DECISION MADE: 22-JAN-16
TUSTIN CA  92780                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medtronic Bio-Medicus Adult Cannula Kit
MEDTRONIC INC.                    510(k) NO: K153598(Special)
ATTN: JENNIFER  TANG              PHONE NO : 765 5266758 
8200 CORAL SEA STREET NE          SE DECISION MADE: 15-JAN-16
MOUNDS VIEW MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spectra Optia Apheresis System
Terumo BCT, Inc                   510(k) NO: K153601(Special)
ATTN: Nicholas  Wong              PHONE NO : 303 2314756 
10811 W. Collins Ave.             SE DECISION MADE: 14-JAN-16
Lakewood CO  80215                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Capillus202
CAPILLUS, LLC                     510(k) NO: K153618(Special)
ATTN: PATRICIA  SCHNOOR           PHONE NO : 786 8881874 
1715 NW 82nd AVE                  SE DECISION MADE: 19-JAN-16
MIAMI FL  33126                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SonoSite Edge II Ultrasound System
FUJIFILM SONOSITE,INC.            510(k) NO: K153626(Third Party - Traditional)
ATTN: Patricia   Liau             PHONE NO : 425 9516870 
21919 30th Dr SE                  SE DECISION MADE: 20-JAN-16
BOTHELL WA  98021-3904            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ROSC-U Mini Chest Compressor (RMCC)
Resuscitation International, LLC  510(k) NO: K153628(Traditional)
ATTN: HAYDEN  FLEMING             PHONE NO : 480 2409495 
17797 N. PERIMETER DR., STE D-105 SE DECISION MADE: 30-JAN-16
SCOTTSDALE AZ  85255              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SALVATION(R) External Fixation System
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K153635(Special)
ATTN: Leslie   Fitch              PHONE NO : 901 8674120 
1023 Cherry Road                  SE DECISION MADE: 13-JAN-16
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal
ALCON LABORATORIES, INC.          510(k) NO: K153642(Special)
ATTN: SHERRI  LAKOTA              PHONE NO : 817 6155472 
6201 SOUTH FREEWAY                SE DECISION MADE: 20-JAN-16
FORT WORTH TX  76134-2099         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
ALCON LABORATORIES, INC.          510(k) NO: K153643(Special)
ATTN: SHERRI  LAKOTA              PHONE NO : 817 6155472 
6201 SOUTH FREEWAY                SE DECISION MADE: 20-JAN-16
FORT WORTH TX  76134-2099         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M.U.S.T. Pedicle Screw System
MEDACTA INTERNATIONAL             510(k) NO: K153664(Special)
ATTN: MICHAEL G. LOITERMAN        PHONE NO : 41 91 6966060 
STRADA REGINA                     SE DECISION MADE: 19-JAN-16
CASTEL SAN PIETRO  CH CH6874      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MultiFIX S Ultra Knotless Fixation System
ArthoCare Corporation             510(k) NO: K153669(Special)
ATTN: Laura  Kasperowicz          PHONE NO : 949 5852406 
15285 Alton Parkway, Suite 200    SE DECISION MADE: 19-JAN-16
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: basixTOUCH40 Inflation Syringe
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K153672(Special)
ATTN: DAN W. LINDSAY              PHONE NO : 801 2084408 
1600 WEST MERIT PKWY.             SE DECISION MADE: 20-JAN-16
SOUTH JORDAN UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Paragon T2 Wand with Integrated Cable
ARTHROCARE CORPORATION            510(k) NO: K153675(Special)
ATTN: KRYSTLE  DANUZ              PHONE NO : 512 3585769 
7000 W. WILLIAM CANNON DRIVE      SE DECISION MADE: 15-JAN-16
AUSTIN TX  78735                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Neptune E-SEP Smoke Evacuation Pencil
STRYKER CORPORATION               510(k) NO: K153679(Special)
ATTN: MAIREAD  TWOMEY             PHONE NO : 00 353 214532988 
4100 E. MILHAM AVENUE             SE DECISION MADE: 22-JAN-16
KALAMAZOO MI  49001               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PleuraFlow System
CLEARFLOW, INC.                   510(k) NO: K153681(Special)
ATTN: DOV  GAL                    PHONE NO : 714 9165010 
S. SUNKIST ST, SUITE E            SE DECISION MADE: 20-JAN-16
ANAHEIM CA  92806                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPIWay Endonasal Access Guide
SPIWAY LLC                        510(k) NO: K153686(Special)
ATTN: EUGENE  CHEN                PHONE NO : 844 5651226 
1120 CALLE CORDILLERA, #102       SE DECISION MADE: 28-JAN-16
SAN CLEMENTE CA  92673            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biomet Spine Fusion System
Biomet Spine LLC.                 510(k) NO: K153695(Special)
ATTN: Kyle  Hoefling              PHONE NO : 303 4658963 
310 Interlocken Parkway, Suite 120SE DECISION MADE: 21-JAN-16
Broomfield CO  80021              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
RADIOMETER AMERICA INC.           510(k) NO: K153712(Traditional)
ATTN: Matt  Ackerman              PHONE NO : 800 7360600 
250 S. KRAEMER BLVD               SE DECISION MADE: 28-JAN-16
BREA CA  92821                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 8F FlowGate2 Balloon Guide Catheter
CONCENTRIC MEDICAL                510(k) NO: K153729(Special)
ATTN: SHAZIA  HAKIM               PHONE NO : 510 4132636 
301 EAST EVELYN AVENUE            SE DECISION MADE: 27-JAN-16
MOUNTAIN VIEW CA  94041           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Release Laminoplasty Fixation System
Pioneer Surgical Technology, Inc. 510(k) NO: K153735(Special)
ATTN: Sarah  Pleaugh              PHONE NO : 906 2269909 
375 River Park Circle             SE DECISION MADE: 21-JAN-16
Marquette MI  49855               510(k) SUMMARY AVAILABLE FROM FDA
                                                    


            TOTAL 510(k)s THIS PERIOD   231                                     
            TOTAL WITH SUMMARIES        223                                     
            TOTAL WITH STATEMENTS        8
                                       

Page Last Updated: 02/03/2016
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