Medical Devices

January 2018 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD January 2018


DEVICE: MiCor A100 Wearable ECG Recorder
MITAC INTERNATIONAL CORP.         510(k) NO: K162665(Traditional)
ATTN: YIHAO  HUANG                PHONE NO : 886 339 62888 
NO. 200, WEN HUA 2ND RD. GUISHAN DSE DECISION MADE: 26-JAN-18
TAOYUAN CITY  TW 33383            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Other-Sonic Transmission Gel
PHARMACEUTICAL INNOVATIONS, INC.  510(k) NO: K163023(Traditional)
ATTN: SHIRLEY J. BERGMAN          PHONE NO : 973 2422900 
897 FRELINGHUYSEN AVE.            SE DECISION MADE: 08-JAN-18
NEWARK NJ  07114                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultra/Phonic Conductivity Gel
PHARMACEUTICAL INNOVATIONS, INC.  510(k) NO: K163024(Traditional)
ATTN: SHIRLEY J. BERGMAN          PHONE NO : 973 2422900 
897 FRELINGHUYSEN AVE.            SE DECISION MADE: 08-JAN-18
NEWARK NJ  07114                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultra/Phonic Scanning Gel
Pharmaceutical Innovations Inc.   510(k) NO: K163026(Traditional)
ATTN: Shirley J. Bergman          PHONE NO : 973 2422900 
897 Frelinghuysen Ave.            SE DECISION MADE: 09-JAN-18
Newark NJ  07114                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultra/Phonic Free Conductivity Gel
PHARMACEUTICAL INNOVATIONS, INC.  510(k) NO: K163027(Traditional)
ATTN: SHIRLEY J. BERGMAN          PHONE NO : 973 2422900 
897 FRELINGHUYSEN AVE.            SE DECISION MADE: 09-JAN-18
NEWARK NJ  07114                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 40-42mm BiPolar Head and 22mm Femoral Head
SIGNATURE ORTHOPAEDICS PTY LTD.   510(k) NO: K163081(Traditional)
ATTN: Declan  Brazil              PHONE NO : 61 2 94285181 
7 SIRIUS ROAD                     SE DECISION MADE: 29-JAN-18
LANE COVE  AU 2066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pelvifine Pelvic Muscle Trainer
Shenzhen Konmed Technology Co., Lt510(k) NO: K163288(Traditional)
ATTN: Tony  Tony                  PHONE NO : 86 755 86704558 
703B, Haide building A, Nanxin RoaSE DECISION MADE: 18-JAN-18
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Action Trackstander models TR1816, TR1820, TR2016, and TR2020
Action Manufacturing Inc.         510(k) NO: K163451(Traditional)
ATTN: Alan  Macht                 PHONE NO : 507 5325940 
1105 Lake Rd.                     SE DECISION MADE: 12-JAN-18
Marshall MN  56258                510(k) STATEMENT
                                                    

DEVICE: Kit Boxes and Kit Plates
Nobel Biocare AB                  510(k) NO: K163600(Traditional)
ATTN: Charlemagne  Chua           PHONE NO : 714 2824800 7830
Vastra Hamngatan 1                SE DECISION MADE: 22-JAN-18
Goteborg  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C2 CryoBalloon Ablation System
C2 Therapeutics, Inc.             510(k) NO: K163684(Traditional)
ATTN: Theresa  Brandner-Allen     PHONE NO : 650 5215921 
303 Convention Way, Suite 1       SE DECISION MADE: 23-JAN-18
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clover 50/Clover60/Clover70 Diagnostic Ultrasound System
SHENZHEN WISONIC MEDICAL TECHNOLOG510(k) NO: K163712(Traditional)
ATTN: JIANG  XIAOSAN              PHONE NO : 86 755 86007788 
1ST AND 5TH FLOOR, NO.6 BUILDING, SE DECISION MADE: 02-JAN-18
SHENZHEN  CN 518055               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endotracheal tube; Reinforced Endotracheal tube
Zhanjiang Star Enterprise Co., Ltd510(k) NO: K170234(Traditional)
ATTN: Rongsheng  Tang             PHONE NO : 86 759 2701619 
NO.1, West Jinhua Rd.             SE DECISION MADE: 17-JAN-18
Zhanjiang  TW 524094              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ET Hybrid Abutment
Hiossen Inc.                      510(k) NO: K170421(Traditional)
ATTN: David  Kim                  PHONE NO : 888 6780001 
85 Ben Fairless Dr.               SE DECISION MADE: 11-JAN-18
Fairless Hills PA  19030          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MiroCam Capsule Endoscope System
IntroMedic Co., Ltd.              510(k) NO: K170438(Traditional)
ATTN: Jinyoung  Lee               PHONE NO : 82 2 8019300 
Suite 1105, 1106, E&C Venture DreaSE DECISION MADE: 30-JAN-18
Seoul  KP 08375                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GLOBAL UNITE Platform Shoulder System
DePuy Ireland UC                  510(k) NO: K170748(Traditional)
ATTN: Carol Sandberg Ming         PHONE NO : 508 9776448 
Loughbeg                          SE DECISION MADE: 11-JAN-18
Ringaskiddy  IE                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AirFit F20
ResMed Ltd                        510(k) NO: K170924(Traditional)
ATTN: Johanna  Wright             PHONE NO : 61 2 88841000 
1 Elizabeth Macarthur Drive       SE DECISION MADE: 03-JAN-18
Bella Vista  AU 2153              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WAVE Clinical Platform
Excel Medical Electronics, LLC    510(k) NO: K171056(Traditional)
ATTN: Lance  Burton               PHONE NO : 866 5738807 
801 Maplewood Dr. STE-25          SE DECISION MADE: 04-JAN-18
Jupiter FL  33458                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EON Portable Reverse Osmosis Water Purification System
Cantel                            510(k) NO: K171099(Traditional)
ATTN: Mike  Halliday              PHONE NO : 484 9910220 
14550 28th Avenue North           SE DECISION MADE: 05-JAN-18
Minneapolis MN  55447             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module
LiNA Medical ApS                  510(k) NO: K171113(Traditional)
ATTN: Natalia  Szychulska         PHONE NO : 48 612 222143 
Formervangen 5                    SE DECISION MADE: 04-JAN-18
Glostrup  DK 2600                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CEREC Ortho Software
Dentsply Sirona                   510(k) NO: K171122(Traditional)
ATTN: Karl J. Nittinger           PHONE NO : 717 8494424 
221 West Philadelphia Street, SuitSE DECISION MADE: 11-JAN-18
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aleo BME Liquid Bandage
Aleo BME Inc.                     510(k) NO: K171148(Traditional)
ATTN: Chao  Liu                   PHONE NO : 814 9547381 
200 Innovations Blvd, Ste. 210A   SE DECISION MADE: 12-JAN-18
State College PA  16803           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M
FUJIFILM Medical Systems U.S.A., I510(k) NO: K171207(Traditional)
ATTN: Jeffrey  Wan                PHONE NO : 973 6862627 
10 High Point Drive               SE DECISION MADE: 11-JAN-18
Wayne NJ  07470                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: One Touch Condom with Benzocaine
Thai Nippon Rubber Industry Public510(k) NO: K171213(Traditional)
ATTN: Pisut  Chanwatarungkull (PetPHONE NO : 662 2108888 
1 Charoenrat Road, Thungwatdon, SaSE DECISION MADE: 12-JAN-18
Bangkok  TH 10120                 510(k) STATEMENT
                                                    

DEVICE: Fiji Anchor
SportWelding GmbH                 510(k) NO: K171228(Traditional)
ATTN: Joerg  Mayer                PHONE NO : 41 44 2046121 
Wagistrasse 6                     SE DECISION MADE: 19-JAN-18
Schlieren  CH 8952                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OmniCap
Respirion, Inc.                   510(k) NO: K171235(Traditional)
ATTN: Ed  Fadel                   PHONE NO : 919 2802534 
101 North Chestnut Street, Suite 2SE DECISION MADE: 04-JAN-18
Winston-Salem NC  27101           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FMS VUE II Fluid Management and Tissue Debridement System
Medos International SARL          510(k) NO: K171237(Traditional)
ATTN: Tatyana  Korsunsky          PHONE NO : 1 508 8283122 
Chemin-Blanc 38                   SE DECISION MADE: 18-JAN-18
Le Locle Neuchatel  CH 2400       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
Epocal Inc.                       510(k) NO: K171247(Traditional)
ATTN: Jennifer  Armstrong         PHONE NO : 613 6883982 2227
2060 Walkley Road                 SE DECISION MADE: 17-JAN-18
Ottawa  CA K1G 3P5                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Royal Flush Catheter
Cook Incorporated                 510(k) NO: K171264(Traditional)
ATTN: Jessica  Swafford           PHONE NO : 812 3353575 104260
750 Daniels Way                   SE DECISION MADE: 25-JAN-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LINK® BiMobile(TM) Dual Mobility System
Waldemar Link Gmbh & Co. KG       510(k) NO: K171273(Traditional)
ATTN: Stefanie  Reimers           PHONE NO : 49 405 3995530 
Barkhausenweg 10                  SE DECISION MADE: 19-JAN-18
Hamburg  DE 22339                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Bronchoscope Model EB-530P
FUJIFILM Medical Systems U.S.A., I510(k) NO: K171291(Traditional)
ATTN: Shraddha S. More            PHONE NO : 973 6862627 
10 High Point Drive               SE DECISION MADE: 19-JAN-18
Wayne NJ  07470                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A7 Anesthesia System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K171292(Traditional)
ATTN: Yanhong  Bai                PHONE NO : 86 755 81885635 
Mindray Building, Keji 12th Road SSE DECISION MADE: 12-JAN-18
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ULab Systems Treatment Planning Software
ULab Systems, Inc.                510(k) NO: K171295(Traditional)
ATTN: Charlie  Wen                PHONE NO : 650 8684935 
101 Jefferson Drive, Suite 212A   SE DECISION MADE: 09-JAN-18
Menlo Park CA  95025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AR_N Type Implant System
Biotem Co., Ltd.                  510(k) NO: K171297(Traditional)
ATTN: Hong Koo Yeo                PHONE NO : 82 70 82204934 
57, Sasang-ro , 401 beon-gil , SasSE DECISION MADE: 31-JAN-18
Busan  KR                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A5 Anesthesia System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K171311(Traditional)
ATTN: Yanhong  Bai                PHONE NO : 86 755 81885635 
Mindray Builday, Keji 12th Road SoSE DECISION MADE: 12-JAN-18
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FortiCore®
Nanovis LLC                       510(k) NO: K171312(Traditional)
ATTN: Matthew  Hedrick            PHONE NO : 877 9076266 
5865 East State Rd. 14            SE DECISION MADE: 22-JAN-18
Columbia City IN  46725           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EM-4000 Specular Microscope
Tomey Corporation                 510(k) NO: K171313(Traditional)
ATTN: Tomoko  Watanabe            PHONE NO : 11 815 25815327 
2-11-33 Noritakeshinmachi Nishiku SE DECISION MADE: 19-JAN-18
Nagoya  JP 4510051                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cNeuro cMRI
Combinostics Oy                   510(k) NO: K171328(Traditional)
ATTN: Lennart  Thurfjell          PHONE NO : 46 730 699057 
Hatanpaan valtatie                SE DECISION MADE: 08-JAN-18
Tampere  FI 33100                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MR4 Laser
Multi Radiance Medical            510(k) NO: K171354(Traditional)
ATTN: Andrey  Godes               PHONE NO : 440 5420761 105___
6521 Davis Industrial Pkwy        SE DECISION MADE: 13-JAN-18
Solon OH  44139                   510(k) STATEMENT
                                                    

DEVICE: CONTEC™ Electrocardiograph
Contec Medical Systems Co., LTD.  510(k) NO: K171360(Traditional)
ATTN: Xueyong  Li                 PHONE NO : 86 355 8015490 
No. 112 QinHuang West Street EconoSE DECISION MADE: 22-JAN-18
QinHuangDao  CN 066012            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)
Sanrea Healthcare Products Pvt Ltd510(k) NO: K171367(Traditional)
ATTN: Jose  Paul M                PHONE NO : 91 491 2970145 
Plot#P-56, Pearl Road, Kinfra IIT SE DECISION MADE: 26-JAN-18
Palakkad  IN 678 621              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alians Elbow Locking Plating System
Newclip Technics                  510(k) NO: K171372(Special)
ATTN: Gaelle  Lussori             PHONE NO : 33 2 28213712 
PA de la Lande Saint Martin - 45 rSE DECISION MADE: 04-JAN-18
Haute-Goulaine  FR 44 115         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker 90-S Max SERFAS Energy Probe
Stryker                           510(k) NO: K171391(Traditional)
ATTN: Ben  Krebs                  PHONE NO : 408 7542000 
5900 Optical Court                SE DECISION MADE: 26-JAN-18
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ODFS Pace XL
Odstock Medical Ltd               510(k) NO: K171396(Traditional)
ATTN: Steven  Crook               PHONE NO : 44 1722 439541 
Salisbury District Hospital       SE DECISION MADE: 31-JAN-18
Salisbury  GB SP2 8BJ             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ePatch
Braemar Manufacturing, LLC        510(k) NO: K171410(Traditional)
ATTN: Kent  Sayler                PHONE NO : 619 2437500 
3890 Murphy Canyon Road, Suite 100SE DECISION MADE: 04-JAN-18
San Diego CA  92123               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IRRIS (Infra-Red-Red Intubation System)
A.R Guide In Medical Ltd.         510(k) NO: K171411(Traditional)
ATTN: Ariel  Shrem                PHONE NO : 972 587 622811 
13 Wadi El Haj                    SE DECISION MADE: 12-JAN-18
Nazareth  IL 17111                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERTICALE® Posterior Spinal Fixation System/VERTICALE® System
Silony Medical GmbH               510(k) NO: K171421(Traditional)
ATTN: Bircan  Yilmaz              PHONE NO : 49 711 78252540 
Leinfelder StraBe 60              SE DECISION MADE: 10-JAN-18
Leinfelden-Echterdingen  DE 70771 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STRONG Dental Handpieces
Saeshin Precision Co., Ltd.       510(k) NO: K171436(Traditional)
ATTN: Choi Jong Woo               PHONE NO : 82 53 5872345 
52, Secheon-ro 1-gil, Dasa-eup, DaSE DECISION MADE: 05-JAN-18
Daegu  KR 42921                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Amplatz Support Wire Guide with Apex Curve
Cook Incorporated                 510(k) NO: K171445(Traditional)
ATTN: Jennifer  Allman            PHONE NO : 812 3353575 104280
750 Daniels Way                   SE DECISION MADE: 10-JAN-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
Meso Scale Diagnostics, LLC       510(k) NO: K171498(Traditional)
ATTN: Lillian  Quintero           PHONE NO : 240 3142600 
1601 Research Boulevard           SE DECISION MADE: 12-JAN-18
Rockville MD  20850               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Uro-V Cystoscope
UroViu Corporation                510(k) NO: K171500(Traditional)
ATTN: Thomas  Lawson              PHONE NO : 650 3975174 
5337 - 14th Place SE              SE DECISION MADE: 30-JAN-18
Bellevue WA  98006                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Electrocardiograph
Biocare Bio-Medical Equipment Co.,510(k) NO: K171517(Special)
ATTN: Hongbo  Zhong               PHONE NO : 86 0755 36615333 
#16-1, Jinhui Road, Jinsha CommuniSE DECISION MADE: 11-JAN-18
Shenzhen  CN 518102               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles
Zhejiang kindly Medical Devices Co510(k) NO: K171518(Traditional)
ATTN: Zenghua  Zhang              PHONE NO : 86 577 86872005 
No.758, 5th Binhai Road, Binhai InSE DECISION MADE: 05-JAN-18
Wenzhou  CN 325025                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)
Avantsonic Technology Co., Ltd.   510(k) NO: K171528(Traditional)
ATTN: Cuiling  Wu                 PHONE NO : 86 075 588271976 
No.394, Jingdongfang Avenue BeibeiSE DECISION MADE: 24-JAN-18
Chongqing  CN 400714              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Snorer's Friend
Scope Healthcare Technologies Pty 510(k) NO: K171529(Abbreviated)
ATTN: Ben  Olsen                  PHONE NO : 1 904 8644530 
13/15 King William Road           SE DECISION MADE: 02-JAN-18
Unley  AU 5061                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: K2M Navigation Instruments
K2M                               510(k) NO: K171556(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
600 Hope Parkway SE               SE DECISION MADE: 16-JAN-18
Leesburge VA  20175               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dentium Ti-Base
Dentium Co., Ltd.                 510(k) NO: K171622(Traditional)
ATTN: Sangpil  Yoon               PHONE NO : 82 312 072200 
150, Eondong-ro Giheung-gu        SE DECISION MADE: 11-JAN-18
Yongin-si  KR 443-270             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Lumen Ovum Aspiration Needles
Willian A. Cook Australia Pty Ltd 510(k) NO: K171625(Special)
ATTN: Gordana  Pozvek             PHONE NO : 61 738 411188 
95 Brandl Street                  SE DECISION MADE: 12-JAN-18
Eight Mile Plains  AU 4113        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HBS2 Headless Bone Screw
Stuckenbrock Medizintechnik GmbH  510(k) NO: K171628(Traditional)
ATTN: Fabian  Stuckenbrock        PHONE NO : 49 7461 165880 
Lessingstraße 50                  SE DECISION MADE: 12-JAN-18
Tuttlingen  DE d-78532            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ortho System
3Shape A/S                        510(k) NO: K171634(Special)
ATTN: Antje  Marquardsen          PHONE NO : 45 702 72620 
Holmens Kanal 7                   SE DECISION MADE: 17-JAN-18
Copenhagen  DK 1060               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microcatheter and guide-wire system
Suzhou Hengrui Disheng Medical Co.510(k) NO: K171665(Traditional)
ATTN: Jingwen  Li                 PHONE NO : 86 512 66806133 
No. 11 Building, No.8 Jinfeng RoadSE DECISION MADE: 11-JAN-18
Suzhou 215163  CN 215163          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Focus Cap
GCE Medical Corporation           510(k) NO: K171673(Traditional)
ATTN: Stanley  Chang              PHONE NO : 1 559 4395757 
2723 West Tenaya                  SE DECISION MADE: 19-JAN-18
Fresno CA  93711                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Angel Align System
Smile Development Corp            510(k) NO: K171674(Traditional)
ATTN: Ian  Kitching               PHONE NO : 408 6211152 
7179 Cherrywood Ct                SE DECISION MADE: 19-JAN-18
Highland CA  92346                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electrodes with silver conductive
Shenzhen Konmed Technology Co., Lt510(k) NO: K171721(Traditional)
ATTN: Tony  Tony                  PHONE NO : 86 206 6393598 
703B, Haide building A, Nanxin RoaSE DECISION MADE: 05-JAN-18
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electrodes with snap / Electrodes with pigtail
Shenzhen Konmed Technology Co., Lt510(k) NO: K171722(Traditional)
ATTN: Tony  Tony                  PHONE NO : 86 755 86704558 
703B, Haide building A, Nanxin RoaSE DECISION MADE: 10-JAN-18
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
Kronus, Inc.                      510(k) NO: K171731(Traditional)
ATTN: Brian  Deis                 PHONE NO : 208 3774800 
170 S. Seneca Springs Way Suite 10SE DECISION MADE: 19-JAN-18
Star ID  83669                    510(k) STATEMENT
                                                    

DEVICE: ACCLARENT AERA Eustachian Tube Balloon Dilation System
Acclarent, Inc.                   510(k) NO: K171761(Traditional)
ATTN: James Patrick Garvey II     PHONE NO : 949 7898505 
33 Technology Drive               SE DECISION MADE: 16-JAN-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ecosite Bulk Fill
DMG USA Inc.                      510(k) NO: K171772(Traditional)
ATTN: Gordon  Craig               PHONE NO : 508 2265660 
23 Frank Mossberg Drive           SE DECISION MADE: 31-JAN-18
Attleboro MA  02703               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Theradome LH80 PRO
Theradome Inc.                    510(k) NO: K171775(Traditional)
ATTN: Tamim  Hamid                PHONE NO : 1 843 8323232 
4900 Hopyard Rd, Ste 100          SE DECISION MADE: 09-JAN-18
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann Dental Implant System
Straumann USA, LLC                510(k) NO: K171784(Traditional)
ATTN: Jennifer M. Jackson         PHONE NO : 978 7472509 
60 Minuteman Road                 SE DECISION MADE: 19-JAN-18
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARROW Reverse Porous Glenoid
Fournitures Hospitalieres Industri510(k) NO: K171789(Traditional)
ATTN: Patricia  Donnard           PHONE NO : 33 298 556895 
ZI de Kernevez - 6 rue Nobel      SE DECISION MADE: 23-JAN-18
Quimper  FR 29000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elos Accurate Customized Abutment, Elos Prosthetic Screw
Elos Medtech Pinol A/S            510(k) NO: K171799(Traditional)
ATTN: Tina Friis Poulsen          PHONE NO : 45 482 16469 
Engvej 33                         SE DECISION MADE: 15-JAN-18
Goerloese  DK DK-3330             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Attain Assist CS Access Catheter
Creganna Medical also doing busine510(k) NO: K171819(Traditional)
ATTN: Olivia  Odhiambo            PHONE NO : 353 91 783469 
Parkmore West                     SE DECISION MADE: 04-JAN-18
Galway  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReddyPort NIV Access Elbow
SMD Manufacturing, LLC            510(k) NO: K171827(Traditional)
ATTN: Rian  Wendling              PHONE NO : 801 8993036 
2500 South State Street, Suite D22SE DECISION MADE: 19-JAN-18
Salt Lake City UT  84115          510(k) STATEMENT
                                                    

DEVICE: Digital Blood Pressure Monitor-Wrist Style
Shenzhen Combei Technology CO., LT510(k) NO: K171833(Traditional)
ATTN: Huaguang  Meng              PHONE NO : 86 0755 29588956 
Floor 5, Block B, Building G, JinxSE DECISION MADE: 10-JAN-18
Guanlan, Shenzhen  CN 518110      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Irradiation Aesthetic Device
Chongqing Peninsula Medical Techno510(k) NO: K171835(Traditional)
ATTN: Zhang  Sudi                 PHONE NO : 86 150 12578550 
No.2-4, 2F BLK1, Biological and BiSE DECISION MADE: 30-JAN-18
Jiulongpo District  CN 404100     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EarlySense Bed Sensing Unit
EarlySense Ltd.                   510(k) NO: K171836(Traditional)
ATTN: Dalia  Argaman              PHONE NO : 972 3 7522330 106
7 Derech Zeev Jabotinsky          SE DECISION MADE: 04-JAN-18
Ramat Gan  IL 5252007             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sureclear aligners
Emergo Global Consulting, LLC     510(k) NO: K171860(Third Party - Traditional)
ATTN: Stuart R. Goldman           PHONE NO : 512 3279997 
2500 Bee Cave Road, Bldg. 1, SuiteSE DECISION MADE: 05-JAN-18
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Electrocardiograph
Edan Instruments, Inc.            510(k) NO: K171942(Special)
ATTN: Alice  Yang                 PHONE NO : 86 755 26859216 
#15 Jinhui Road,Jinsha Community KSE DECISION MADE: 24-JAN-18
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Roadrunner Extra Support Wire Guide
Cook Incorporated                 510(k) NO: K171948(Special)
ATTN: Jennifer  Allman            PHONE NO : 812 3353575 104280
750 Daniels Way                   SE DECISION MADE: 05-JAN-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearLine IV
ClearLine MD                      510(k) NO: K171954(Traditional)
ATTN: Rick  Romeo                 PHONE NO : 781 9336500 
300 TradeCenter, Suite 5400       SE DECISION MADE: 25-JAN-18
Woburn MA  01801                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE
Mectron SPA                       510(k) NO: K171958(Traditional)
ATTN: Franco  Zunino              PHONE NO : 39 0185 35361 
Via Loreto 15                     SE DECISION MADE: 12-JAN-18
Carasco  IT 16042                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EchoGlo Needle
Smiths Medical ASD, Inc.          510(k) NO: K171968(Traditional)
ATTN: Michael R. Johnson          PHONE NO : 1 763 3833341 
6000 Nathan Lane North            SE DECISION MADE: 25-JAN-18
Minneapolis MN  55442             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer
Lite-On Technology Corp. H.S.P.B. 510(k) NO: K171971(Traditional)
ATTN: John  Lo                    PHONE NO : 886 3 5787722 5804
8, Dusing Road, Hsinchu Science PaSE DECISION MADE: 25-JAN-18
Hsinchu City  TW 30078            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EnsoETM
Attune Medical                    510(k) NO: K172029(Traditional)
ATTN: Erik  Kulstad               PHONE NO : 312 7254756 
3440 S. Dearborn St. #215-South   SE DECISION MADE: 05-JAN-18
Chicago IL  60616                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter
Cook Incorporated                 510(k) NO: K172051(Traditional)
ATTN: Naomi  Funkhouser           PHONE NO : 1 812 3353575 104371
750 Daniels Way, P.O. Box 489     SE DECISION MADE: 10-JAN-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECHELON OVAL V6.0A MRI System
Hitachi Healthcare Americas Corpor510(k) NO: K172110(Traditional)
ATTN: Doug  Thistlethwaite        PHONE NO : 330 4251313 
1959 Summit Commerce Park         SE DECISION MADE: 11-JAN-18
Twinsburg OH  44087               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)
Stryker Corporation               510(k) NO: K172116(Traditional)
ATTN: Kristi  Ashton              PHONE NO : 269 3895929 
4100 E. Milham Avenue             SE DECISION MADE: 25-JAN-18
Kalamazoo MI  49001               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Getinge GSS67N Series Steam Sterilizer
Maquet GmbH                       510(k) NO: K172159(Traditional)
ATTN: Holger  Ullrich             PHONE NO : 49 722 29321550 
Kehler Strasse 31                 SE DECISION MADE: 30-JAN-18
Rastatt  DE 76437                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROPEL Device
Propel Orthodontics LLC           510(k) NO: K172164(Traditional)
ATTN: Bryce  Way                  PHONE NO : 408 3945851 
394 South Abbott Ave              SE DECISION MADE: 17-JAN-18
Milpitas CA  95035                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulpdent (Activa) Pit and Fissure Sealant with MCP
Pulpdent Corporation              510(k) NO: K172169(Traditional)
ATTN: Kenneth J. Berk             PHONE NO : 1 617 9266666 
80 Oakland Street                 SE DECISION MADE: 05-JAN-18
Watertown MA  02472               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Guided Growth Plate System Plus
Orthofix Srl                      510(k) NO: K172183(Traditional)
ATTN: Gianluca  Ricadona          PHONE NO : 39 045 6719000 
Via Delle Nazioni 9               SE DECISION MADE: 09-JAN-18
Bussolengo  IT 37012              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt
Truemed Group LLC                 510(k) NO: K172189(Traditional)
ATTN: Nina Galeana Rodriguez      PHONE NO : 1 832 4422310 
2002 Timberloch Place Suite 200   SE DECISION MADE: 16-JAN-18
The Woodlands TX  77380           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules
Alma Lasers Inc.                  510(k) NO: K172193(Traditional)
ATTN: Rekha  Anand                PHONE NO : 224 3772000 2019
485 Half Day Road Suite # 100     SE DECISION MADE: 09-JAN-18
Buffalo Grove IL  60089           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HYDRASHIFT 2/4 daratumumab, daratumumab Control
Sebia                             510(k) NO: K172195(Traditional)
ATTN: Karen  Anderson             PHONE NO : 770 4463707 3704
1705 Corporate Drive, Suite 400   SE DECISION MADE: 11-JAN-18
Norcross GA  30093                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ExoToe Staple
ExoToe LLC                        510(k) NO: K172205(Traditional)
ATTN: Avi  Roop                   PHONE NO : 650 8672820 
Po Box 548                        SE DECISION MADE: 11-JAN-18
Grimes IA  50111                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™
CTL Medical Corporation           510(k) NO: K172212(Traditional)
ATTN: Tosan  Onosode              PHONE NO : 214 5455820 
4550 Excel Parkway, Suite 300     SE DECISION MADE: 09-JAN-18
Addison TX  75001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DTX Studio diagnose
Nobel Biocare AB                  510(k) NO: K172224(Traditional)
ATTN: Charlemagne  Chua           PHONE NO : 714 2824800 5030
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 11-JAN-18
Goteborg  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPI Dental Implant System
MSI France                        510(k) NO: K172240(Traditional)
ATTN: Gerard  Bouna               PHONE NO : 6 5 2129536 
5 Rue des Halles                  SE DECISION MADE: 31-JAN-18
Paris  FR 75001                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PulsioFlex Monitoring System
PULSION Medical Systems SE        510(k) NO: K172259(Traditional)
ATTN: Marc  Bergenthal            PHONE NO : 49 89 4599140 
Hans-Riedl-Str. 17                SE DECISION MADE: 18-JAN-18
Feldkirchen  DE 85622             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ipsogen JAK2 RGQ PCR Kit
QIAGEN, Inc.                      510(k) NO: K172287(Traditional)
ATTN: Lindsey  Howard             PHONE NO : 1 240 6867826 
19300 Germantown Road             SE DECISION MADE: 12-JAN-18
Germantown MD  20874              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TruAbutment DS
TruAbutment Inc.                  510(k) NO: K172304(Traditional)
ATTN: Brandon  Kim                PHONE NO : 1 714 9561488 
300 South Harbor Blvd #520        SE DECISION MADE: 23-JAN-18
Anaheim CA  92805                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
STERIS Corporation                510(k) NO: K172319(Traditional)
ATTN: Bill  Brodbeck              PHONE NO : 440 3542600 
5960 Heisley Rd                   SE DECISION MADE: 18-JAN-18
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smith & Nephew Patient Matched Cutting Blocks
Smith & Nephew, Inc.              510(k) NO: K172336(Special)
ATTN: Brad  Sheals                PHONE NO : 901 3996897 
7135 Goodlett Farms Parkway       SE DECISION MADE: 10-JAN-18
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Instalief
Privi Medical Pte Ltd             510(k) NO: K172358(Traditional)
ATTN: Prusothman M Sinha Raja     PHONE NO : 415 9065188 
79 Ayer Rajah Crescent #05-03     SE DECISION MADE: 10-JAN-18
Singapore  SG 139955              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quickie(r) Q700-UP M
Sunrise Medical (US) LLC          510(k) NO: K172384(Traditional)
ATTN: Nancy J. Gertlar            PHONE NO : 559 2942395 
2842 Business Park Ave            SE DECISION MADE: 16-JAN-18
Fresno CA  93727                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARBOR External Fixation System
Globus Medical Inc.               510(k) NO: K172438(Traditional)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 
2560 General Armistead Ave.       SE DECISION MADE: 12-JAN-18
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bruxor
Sleep Specialties, LLC            510(k) NO: K172452(Traditional)
ATTN: James S. Fallon             PHONE NO : 949 7023797 
2565 South Las Vegas Blvd.,Suite #SE DECISION MADE: 11-JAN-18
Las Vegas NV  89109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bone Screws 6.5mm
LimaCorporate S.p.A.              510(k) NO: K172456(Special)
ATTN: Michela  Zanotto            PHONE NO : 39 0432 945511 
Via Nazionale, 52 33038 Villanova SE DECISION MADE: 04-JAN-18
Udine  IT                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate
Biomet Manufacturing Corp         510(k) NO: K172502(Traditional)
ATTN: Patricia Sandborn Beres     PHONE NO : 574 2676639 
56 E. Bell Drive                  SE DECISION MADE: 03-JAN-18
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spineology Navigation Instruments
Spineology Inc.                   510(k) NO: K172518(Traditional)
ATTN: Jacqueline  Hauge           PHONE NO : 651 2568500 
7800 3rd Street N., Suite 600     SE DECISION MADE: 05-JAN-18
Scandia MN  55128                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wiltrom Spinal Fixation System
Wiltrom Corporation Limited       510(k) NO: K172548(Traditional)
ATTN: Yi-Chun  Su                 PHONE NO : 886 3 6107168 
1F., No. 26, Sec. 2, Shengy Rd.   SE DECISION MADE: 12-JAN-18
Zhubei City  TW 30261             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GORE Molding and Occlusion Balloon Catheter
W.L Gore And Associates Inc       510(k) NO: K172567(Traditional)
ATTN: Jeremiah  Andrews           PHONE NO : 623 2345084 
1505 N. Fourth Street             SE DECISION MADE: 31-JAN-18
Flagstaff AZ  86004               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap
BAROnova, Inc.                    510(k) NO: K172575(Traditional)
ATTN: Lian  Cunningham            PHONE NO : 650 6389796 
1509 Industrial Road              SE DECISION MADE: 18-JAN-18
San Carlos CA  94070              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci Xi Surgical System; da Vinci X Surgical System
Intuitive Surgical, Inc.          510(k) NO: K172643(Traditional)
ATTN: Brandon  Hansen             PHONE NO : 408 5232100 
1266 Kifer Road                   SE DECISION MADE: 31-JAN-18
Sunnyvale AL  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Automated ankle brachial pressure index measuring device
Mesi D.O.O.; Mesi, Development of 510(k) NO: K172655(Traditional)
ATTN: Jakob  Susteric             PHONE NO : 386 1 6203487 
Letaliska cesta 3C                SE DECISION MADE: 11-JAN-18
Ljubljana  SI 1000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: reVive Perioral
LED Technologies, Inc.            510(k) NO: K172662(Traditional)
ATTN: Lloyd  Nelson               PHONE NO : 303 4076884 
6000 Greenwood Plaza Blvd., Suite SE DECISION MADE: 09-JAN-18
Greenwood Village CO  80111       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Yamahachi Pink CAD/CAM Disk
Yamahachi Dental Mfg., Co.        510(k) NO: K172683(Traditional)
ATTN: Shogo  Muramatsu            PHONE NO : 81 533 577121 
54-1, Ochigara Nishiura-Cho       SE DECISION MADE: 16-JAN-18
Gamamori-City  JP 443-0105        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORZA® XP Expandable Spacer System
Orthofix Inc.                     510(k) NO: K172696(Traditional)
ATTN: Natalia  Volosen            PHONE NO : 214 9372145 
3451 Plano Parkway                SE DECISION MADE: 19-JAN-18
Lewisville TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIO-C SEALER
Angelus Industria de Produtos Odon510(k) NO: K172701(Traditional)
ATTN: Paulo Sergio Calixto de OlivPHONE NO : 55 43 21013205 
Rua Waldir Landgraf, 101          SE DECISION MADE: 04-JAN-18
Londrina  BR 86.031-218           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tec 820, Tec 850
Datex-Ohmeda, Inc.                510(k) NO: K172702(Traditional)
ATTN: Trishia  Mercier            PHONE NO : 608 6958319 
3030 Ohmeda Drive, PO Box 7550    SE DECISION MADE: 04-JAN-18
Madison WI  53707-7550            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: V2K Rinspiration System, P7 Catheter - 9mm Rinse x 135cm Working Length, V2K Rinspiration System, P7 Catheter - 20mm Rinse x 135cm Working Length, V2K Rinspiration System, Filter Line - 108" Length
V2K Medical Inc.                  510(k) NO: K172716(Traditional)
ATTN: Jake  Wolenberg             PHONE NO : 408 9405587 
1221 Innsbruck Drive              SE DECISION MADE: 26-JAN-18
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
Stryker Trauma Gmbh               510(k) NO: K172774(Traditional)
ATTN: Heike  Gustke               PHONE NO : 49 4348 702637 
Prof-Kuentscher-Str. 1-5          SE DECISION MADE: 12-JAN-18
Schoenkirchen  DE 24232           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumilisse IPL Hair Remover
Conair Corporation                510(k) NO: K172791(Traditional)
ATTN: Mike  Cantrell              PHONE NO : 203 9754617 
One Cummings Point Road           SE DECISION MADE: 18-JAN-18
Stamford CT  06902                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flex Robotic System and Flex Transabdominal Drive
MEDROBOTICS CORPORATION           510(k) NO: K172796(Traditional)
ATTN: Linda J Varroso             PHONE NO : 508 6926460 
475 Paramount Drive               SE DECISION MADE: 18-JAN-18
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann CARES Abutments CoCr
Institut Straumann AG             510(k) NO: K172798(Traditional)
ATTN: Shokoufeh  Khodabandeh      PHONE NO : 41 61 9651260 
Peter Merian Weg 12               SE DECISION MADE: 03-JAN-18
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Besmed Peak Flow Meter
Besmed Health Business Corp.      510(k) NO: K172804(Traditional)
ATTN: Lawrence  Wu                PHONE NO : 886 2 22903959 211
No.5, Lane 116, Wu-Kong 2nd Rd    SE DECISION MADE: 11-JAN-18
Wu-Ku District  TW                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TiGer Shark™ System
Choice Spine, LP.                 510(k) NO: K172816(Traditional)
ATTN: Kim  Finch                  PHONE NO : 865 2433375 
400 Erin Drive                    SE DECISION MADE: 26-JAN-18
Knoxville TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Symetri Clear
Ormco Corporation                 510(k) NO: K172845(Traditional)
ATTN: Tara  Bonny                 PHONE NO : 909 9625856 
1717 W. Collins Avenue            SE DECISION MADE: 31-JAN-18
Orange CA  92867                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PreOp
Epilog                            510(k) NO: K172858(Traditional)
ATTN: Gregor  Strobbe             PHONE NO : 32 484 777651 
Vlasgaardstraat 52                SE DECISION MADE: 08-JAN-18
Ghent  BE 9000                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System
ShenZhen Mindray Bio-Medical Elect510(k) NO: K172860(Traditional)
ATTN: Ma  Chao                    PHONE NO : 86 755 81886573 
Mindray Building, Keji 12th Road SSE DECISION MADE: 02-JAN-18
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SedLine Sedation Monitor
Masimo Corporation                510(k) NO: K172890(Traditional)
ATTN: Matthew  Tiacharoen         PHONE NO : 949 2977982 
52 Discovery                      SE DECISION MADE: 26-JAN-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312
Shenzhen Jiacom Technology Co ., L510(k) NO: K172896(Traditional)
ATTN: Luo  Tianfeng               PHONE NO : 86 755 29015600 
No. A6 Building, Silicon Valley PoSE DECISION MADE: 26-JAN-18
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cobas Factor II and Factor V Test
Roche Molecular Systems, Inc.     510(k) NO: K172913(Traditional)
ATTN: Pooja  Shah                 PHONE NO : 925 7308886 
4300 Hacienda Drive               SE DECISION MADE: 12-JAN-18
Pleasanton CA  94588-2722         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3D APT
Philips Medical Systems Nederland 510(k) NO: K172920(Abbreviated)
ATTN: Jan van de Kerkhof          PHONE NO : 31 61 3300542 
Veenpluis 4-6                     SE DECISION MADE: 22-JAN-18
Best  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath
Boston Scientific Corporation     510(k) NO: K172929(Traditional)
ATTN: Daniel  FitzDaniel          PHONE NO : 508 6834156 
100 Boston Scientific Way         SE DECISION MADE: 10-JAN-18
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mini TENS DEVICE (Model: KRES102), TENS &EMS DEVICE (Model: KRES100B)
Shenzhen Conree Technology Co.,Ltd510(k) NO: K172933(Traditional)
ATTN: Rihua  Meng                 PHONE NO : 86 0755 36971650 
Room 210, No 2 Industry Building, SE DECISION MADE: 26-JAN-18
Shenzhen  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Embrace
Empatica  Srl                     510(k) NO: K172935(Traditional)
ATTN: Simone  Tognetti            PHONE NO : 0039 334 3078626 
Via Stendhal 36                   SE DECISION MADE: 26-JAN-18
Milano  IT 20144                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein
Beta Healthcare Products Pvt.Ltd. 510(k) NO: K172942(Abbreviated)
ATTN: Boney  Moolayil             PHONE NO : 91 484 2413389 
Plot No 21B, Cochin Special EconomSE DECISION MADE: 08-JAN-18
Kochi  IN 682037                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nurture Rest
Neonatal Loving Kare, Inc.        510(k) NO: K172962(Traditional)
ATTN: Nicole  Sawyers             PHONE NO : 814 5904519 
1702 Treasure Lake                SE DECISION MADE: 18-JAN-18
DuBois PA  15801                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hair Up
Y&J BIO Co., Ltd.                 510(k) NO: K172968(Traditional)
ATTN: Kwang Sic Kim               PHONE NO : 82 3400 0325 
No. C-413, Munjeong Hyundai KnowleSE DECISION MADE: 05-JAN-18
Seoul  KR 05836                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Essence 55S Large Monitor System
Shenyang Torch-Bigtide Digital Tec510(k) NO: K172969(Traditional)
ATTN: Fu  Ailing                  PHONE NO : 86 24 88087606 
Shenbei New District NO. 18-6B, YaSE DECISION MADE: 26-JAN-18
Shenyang  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel
Nanova Biomaterials Inc           510(k) NO: K172977(Traditional)
ATTN: Andrew C. Ritts             PHONE NO : 573 8756682 
3806 Mojave Ct                    SE DECISION MADE: 16-JAN-18
Columbia MO  65202                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diazyme EZ Vitamin D Assay
Diazyme Laboratories              510(k) NO: K172992(Traditional)
ATTN: Abhijit  Datta              PHONE NO : 858 4554762 
12889 Gregg Court                 SE DECISION MADE: 11-JAN-18
Poway CA  92130                   510(k) STATEMENT
                                                    

DEVICE: OBA-MCP, Orthodontic Bracket Adhesive with MCP
Pulpdent Corporation              510(k) NO: K173020(Traditional)
ATTN: Kenneth J. Berk             PHONE NO : 617 9266666 
80 Oakland Street                 SE DECISION MADE: 17-JAN-18
Watertown MA  02472               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems
Supersonic Imagine                510(k) NO: K173021(Traditional)
ATTN: Laurence  Hermitte          PHONE NO : 33 442 992424 
Les Jardins de la Duranne - Bat E&SE DECISION MADE: 09-JAN-18
Aix-en-Provence  FR 13857         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navigo Workstation Version 2.0
UC-Care Ltd.                      510(k) NO: K173054(Traditional)
ATTN: Hadas  Sheynise             PHONE NO : 972 4 9097427 
Apollo Bldg.,New Industrial Zone, SE DECISION MADE: 16-JAN-18
Yokneam  IL 20692                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version
Fisher and Paykel Healthcare Limit510(k) NO: K173060(Traditional)
ATTN: Ashley  Nguyen              PHONE NO : 64 9 5740123 
15 Maurice Paykel Place           SE DECISION MADE: 25-JAN-18
Auckland  NZ 2013                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))
V&Q Manufacturing Corporation     510(k) NO: K173062(Traditional)
ATTN: Jacky  Jin                  PHONE NO : 86 27 87680925 
#B1614 optical valley time square,SE DECISION MADE: 25-JAN-18
Wuhan  CN 430074                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: invendoscopy E210 System
invendo medical GmbH              510(k) NO: K173085(Traditional)
ATTN: Oliver v. Ruepprecht        PHONE NO : 49 8233 7449816 
Peterhofstr. 3 b                  SE DECISION MADE: 08-JAN-18
Kissing  DE 86438                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitrea Software Toshiba Package VSTP-001A
Toshiba Medical Systems Corporatio510(k) NO: K173088(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 31-JAN-18
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4
Toshiba Medical Systems Corporatio510(k) NO: K173090(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 11-JAN-18
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Disposable Electronic Thermometer Probe Cover
Medline Industries, Inc.          510(k) NO: K173113(Traditional)
ATTN: Dinah  Rincones             PHONE NO : 847 9492687 
Three Lake Drive                  SE DECISION MADE: 17-JAN-18
Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DRI OCT Triton
Topcon Corporation                510(k) NO: K173119(Traditional)
ATTN: Charles  Reisman            PHONE NO : 201 5595283 
75-1 Hasunuma-cho, Itabashi-ku    SE DECISION MADE: 19-JAN-18
Tokyo  JP 174-8580                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cervical Spinal Truss System (CSTS) Interbody Fusion Device
4Web, Inc.                        510(k) NO: K173159(Traditional)
ATTN: Jessee  Hunt                PHONE NO : 800 2857090 
2801 Network Blvd.,Suite 620      SE DECISION MADE: 08-JAN-18
Frisco TX  75034                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Epicardia Anywhere
Medicomp, Inc.                    510(k) NO: K173170(Special)
ATTN: Sean  Marcus                PHONE NO : 321 6760010 
600 Atlantis Rd                   SE DECISION MADE: 10-JAN-18
Melbourne FL  32904               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SUNTOUCH Dental Dressing
Huizhou Foryou Medical Devices Co.510(k) NO: K173196(Traditional)
ATTN: Junfeng  Zhang              PHONE NO : 86 752 5302186 
North Shangxia Rd., Dongjiang Hi-tSE DECISION MADE: 24-JAN-18
Huizhou  CN 516005                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Facet Screw Fixation System
U&i Corporation                   510(k) NO: K173198(Traditional)
ATTN: Yeon-Jung  Choi             PHONE NO : 82 31 8606838 
20, Sandan-ro 76 eon-gil(Rd)      SE DECISION MADE: 03-JAN-18
Uijeongbu-si  KR 11781            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Choice Spine Laminoplasty™ Fixation System
Choice Spine, LP                  510(k) NO: K173215(Traditional)
ATTN: Kim  Finch                  PHONE NO : 865 2433375 
400 Erin Drive                    SE DECISION MADE: 19-JAN-18
Knoxville TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAMPYLOBACTER QUIK CHEK
Techlab, Inc.                     510(k) NO: K173217(Traditional)
ATTN: Donna T. Link               PHONE NO : 540 9531664 
2001 Kraft Drive                  SE DECISION MADE: 22-JAN-18
Blacksburg VA  24060              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAMPYLOBACTER CHEK
Techlab, Inc.                     510(k) NO: K173219(Traditional)
ATTN: Donna T. Link               PHONE NO : 540 9531664 
2001 Kraft Drive                  SE DECISION MADE: 22-JAN-18
Blacksburg VA  24060-6358         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Swiss LithoClast Trilogy
E.M.S Electro Medical Systems SA  510(k) NO: K173234(Traditional)
ATTN: Sonia  Callegaro            PHONE NO : 41 22 9944700 
Ch de la Vuarpilliere, 31         SE DECISION MADE: 10-JAN-18
Nyon  CH 1260                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile
Scientia Vascular LLC             510(k) NO: K173235(Third Party - Traditional)
ATTN: David  Sabodski             PHONE NO : 888 3859016 
3487 West 2100 South Suite 100    SE DECISION MADE: 22-JAN-18
West Valley City UT  84119        510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Arthrex PushLock
Arthrex Inc.                      510(k) NO: K173240(Traditional)
ATTN: David L. Rogers             PHONE NO : 1 239 6435553 71924
1370 Creekside Boulevard          SE DECISION MADE: 16-JAN-18
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)
Becton, Dickinson, and Company    510(k) NO: K173252(Traditional)
ATTN: Laura  Stewart              PHONE NO : 410 3164435 
7 Loveton Circle MC 694           SE DECISION MADE: 05-JAN-18
Sparks MD  21152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xpert Carba-R
Cepheid                           510(k) NO: K173263(Traditional)
ATTN: Yi-Ping  Lin                PHONE NO : 408 4006838 
904 Caribbean Drive               SE DECISION MADE: 09-JAN-18
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ToggleLoc System
Biomet Inc.                       510(k) NO: K173278(Traditional)
ATTN: Kyle  Ponce                 PHONE NO : 973 2999300 2125
56 East Bell Drive                SE DECISION MADE: 05-JAN-18
Warsaw IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reliance Lumbar IBF System
Reliance Medical Systems, LLC     510(k) NO: K173283(Special)
ATTN: Bret M. Berry               PHONE NO : 801 2953280 
545 West 500 South Suite 100      SE DECISION MADE: 19-JAN-18
Bountiful UT  84010               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JOULE SYSTEM
Sciton, Inc                       510(k) NO: K173285(Traditional)
ATTN: Jay M. Patel                PHONE NO : 650 5438348 
925 Commercial Street             SE DECISION MADE: 29-JAN-18
Palo Alto CA  94303               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 6440 Ultrasound System
Esaote S.p.A                      510(k) NO: K173291(Traditional)
ATTN: Massimo  Polignano          PHONE NO : 39 055 4229402 
Via Enrico Melen 77               SE DECISION MADE: 12-JAN-18
Genova  IT 16152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVOS Small Fragment Upper Extremity Plates
Smith & Nephew, Inc.              510(k) NO: K173293(Traditional)
ATTN: Samantha  Staubach          PHONE NO : 901 3996132 
1450 Brooks Road                  SE DECISION MADE: 08-JAN-18
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DRAGON X SPSL4HC, DRAGON X SPSL8HC
Sedecal SA                        510(k) NO: K173299(Special)
ATTN: MaLuisa  Gomez de Aguero    PHONE NO : 34 91 6290721 
Pelaya, 9 Pol, Pol. Ind. "Rio De JSE DECISION MADE: 26-JAN-18
Algete  ES 28110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioSphere MIS Putty (BioSphere MIS)
Synergy Biomedical, Llc           510(k) NO: K173301(Special)
ATTN: Mark  Borden                PHONE NO : 484 9028141 
100 Springhouse Dr. Suite 108     SE DECISION MADE: 19-JAN-18
Collegeville PA  19426            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EZ Plate
Zavation Medical Products Llc     510(k) NO: K173306(Traditional)
ATTN: Matt  Jones                 PHONE NO : 601 9191119 
220 Lakeland Parkway              SE DECISION MADE: 22-JAN-18
Flowood MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navigated INFINITY™ Instruments
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K173338(Traditional)
ATTN: Tejas  Patel                PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 18-JAN-18
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cycler Drain Bag Set
Fresenius Medical Care Renal Thera510(k) NO: K173363(Traditional)
ATTN: Denise  Oppermann           PHONE NO : 781 6994479 
920 Winter Street                 SE DECISION MADE: 24-JAN-18
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vantage Galan 3T, V4.6
Toshiba Medical Systems Corporatio510(k) NO: K173382(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 26-JAN-18
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rex Medical Aspiration Pump
Rex Medical, L.P.                 510(k) NO: K173389(Traditional)
ATTN: Erich  Bressler             PHONE NO : 610 9400665 
555 E. North Ln. Suite 5035       SE DECISION MADE: 30-JAN-18
Conshohocken PA  19428            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zimmer Persona Personalized Knee System
Zimmer, Inc.                      510(k) NO: K173417(Traditional)
ATTN: Nicole  Meredith            PHONE NO : 574 3773718 
P.O. Box 708                      SE DECISION MADE: 30-JAN-18
Warsaw IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeQure® NF and SeQure® Microcatheters
Accurate Medical Therapeutics Ltd.510(k) NO: K173430(Traditional)
ATTN: Eran  Miller                PHONE NO : 972 54 3386871 
21 Habarzel Street                SE DECISION MADE: 26-JAN-18
Tel-Aviv  IL 6971029              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Luma Light System
Luma Therapeutics                 510(k) NO: K173436(Traditional)
ATTN: Tiffini  Wittwer            PHONE NO : 415 2541148 
10 Rollins Rd Suite 120           SE DECISION MADE: 30-JAN-18
Millbrae CA  94030                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: gammaCore-S
electroCore, LLC                  510(k) NO: K173442(Traditional)
ATTN: Mike  Romaniw               PHONE NO : 973 2900097 
150 Allen Road, Suite 201         SE DECISION MADE: 23-JAN-18
Basking Ridge NJ  07920           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CliniCloud Stethoscope
StethoCloud Pty.Ltd (CliniCloud)  510(k) NO: K173448(Third Party - Traditional)
ATTN: Andrew  Lin                 PHONE NO : 
Level 5, 141 Flinders Lane        SE DECISION MADE: 25-JAN-18
Melbourne VIC  AU 3000            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ViewPoint 6
GE Medical Systems Ultrasound and 510(k) NO: K173456(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 6766120 
Care Diagnostics, LLC 9900 W InnovSE DECISION MADE: 05-JAN-18
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Panthera Dental Milled Bars
Panthera Dental Inc.              510(k) NO: K173466(Traditional)
ATTN: Martine  Fortin             PHONE NO : 418 5270388 
2035 rue du Haut-Bord             SE DECISION MADE: 26-JAN-18
Quebec City  CA G1n 4n7           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 16ch T/R Hand Wrist Coil
Quality Electrodynamics, LLC      510(k) NO: K173469(Traditional)
ATTN: Eric  Yeh                   PHONE NO : 440 4842940 
6655 Beta Drive Suite 100         SE DECISION MADE: 09-JAN-18
Mayfield Village OH  44143        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic
Shenzhen Mindray Bio-medical Elect510(k) NO: K173471(Traditional)
ATTN: Yang  Zhaohui               PHONE NO : 86 755 81888998 
Mindray Building, Keji 12th Road SSE DECISION MADE: 08-JAN-18
ShenZhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tritanium® TL Curved Posterior Lumbar Cage
Stryker                           510(k) NO: K173476(Traditional)
ATTN: Nikin  Desai                PHONE NO : 201 7498388 
2 Pearl Court                     SE DECISION MADE: 18-JAN-18
Allendale NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OnSight 3D Extremity System
Carestream Health, Inc.           510(k) NO: K173478(Special)
ATTN: Victoria A. Wheeler         PHONE NO : 585 6278706 
150 Verona Street                 SE DECISION MADE: 19-JAN-18
Rochester NY  14608               510(k) STATEMENT
                                                    

DEVICE: NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)
Novo Nordisk Inc.                 510(k) NO: K173479(Traditional)
ATTN: Devraj  Chakravarty         PHONE NO : 609 7865564 
P.O. Box 846                      SE DECISION MADE: 17-JAN-18
Plainsboro NJ  08536              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: K-Y Silicone
Reckitt Benckiser LLC             510(k) NO: K173504(Traditional)
ATTN: Elizabeth  Viguerie         PHONE NO : 973 4042715 
399 Interpace Parkway             SE DECISION MADE: 12-JAN-18
Parsippany NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Everest Spinal System
K2M                               510(k) NO: K173508(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
600 Hope Parkway SE               SE DECISION MADE: 09-JAN-18
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeaSpine Cabo ACP (Anterior Cervical Plate) System
SeaSpine Orthopedics Corporation  510(k) NO: K173521(Traditional)
ATTN: Gina  Flores                PHONE NO : 760 2165136 
5770 Armada Drive                 SE DECISION MADE: 24-JAN-18
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Indego(R)
Parker-Hannifin Corporation       510(k) NO: K173530(Traditional)
ATTN: Achilleas  Dorotheou        PHONE NO : 216 8962044 
1390 E. Highland Road             SE DECISION MADE: 31-JAN-18
Macedonia OH  44056               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arterys Oncology DL
Arterys Inc.                      510(k) NO: K173542(Traditional)
ATTN: John  Axerio-Cilies         PHONE NO : 650 3917111 
51 Federal Street Suite 305       SE DECISION MADE: 25-JAN-18
San Francisco CA  94107           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImagenUniversal
Cardiovascular Imaging Technologie510(k) NO: K173547(Traditional)
ATTN: James A. Case               PHONE NO : 816 5312842 
4320 Wornall Road, Suite 114      SE DECISION MADE: 12-JAN-18
Kansas City UT  64111             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope
PENTAX of America, Inc.           510(k) NO: K173554(Traditional)
ATTN: James W. Monroe             PHONE NO : 201 5712300 
3 Paragon Drive                   SE DECISION MADE: 19-JAN-18
Montvale NJ  07645-1782           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SyMRI
SyntheticMR AB                    510(k) NO: K173558(Traditional)
ATTN: Maria  Almesaker            PHONE NO : 46 0 704151007 
Storgatan 11                      SE DECISION MADE: 26-JAN-18
Linkoping  SE 58223               510(k) STATEMENT
                                                    

DEVICE: Barrx SB RFA Endoscopic Catheter
Covidien llc                      510(k) NO: K173559(Special)
ATTN: Saket  Bhatt                PHONE NO : 408 3287357 
15 Hampshire Street               SE DECISION MADE: 18-JAN-18
Mansfield MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microcatheter
Surmodics, Inc.                   510(k) NO: K173560(Traditional)
ATTN: Sherri  Mellingen           PHONE NO : 952 5007081 
9924 W 74th St                    SE DECISION MADE: 12-JAN-18
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE
TZ Medical Inc                    510(k) NO: K173563(Traditional)
ATTN: John  Lubisich              PHONE NO : 503 6390282 
17750 SW Upper Boones Ferry Rd #15SE DECISION MADE: 10-JAN-18
Portland OR  97224                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gallant PTCA Dilatation Catheter
Medinol, Ltd.                     510(k) NO: K173581(Traditional)
ATTN: Marina Tikhonov  Demishtein PHONE NO : 972 3 7679000 
Kiryat Atidim, Bldg. 8            SE DECISION MADE: 25-JAN-18
Tel Aviv  IL 6158101              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes
ThermiGen, L.L.C                  510(k) NO: K173582(Traditional)
ATTN: Suzanne  Cheang             PHONE NO : 214 8880683 
3131 West Royal Lane, Suite 100   SE DECISION MADE: 17-JAN-18
Irving TX  75063                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader
3M Company                        510(k) NO: K173584(Traditional)
ATTN: Hilary B. Hovde             PHONE NO : 651 7360364 
3M Center, Building 275-5W-06     SE DECISION MADE: 22-JAN-18
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Illumeo System
Philips Medical Systems Technologi510(k) NO: K173588(Special)
ATTN: Yoram  Levy                 PHONE NO : 972 4 8310224 
PO Box 325 Building 34            SE DECISION MADE: 12-JAN-18
Haifa  IL 3100202                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rusch Intermittent Urethral Catheters
Teleflex Medical                  510(k) NO: K173596(Traditional)
ATTN: Amanda  Webb                PHONE NO : 919 4338050 
3015 Carrington Mill Blvd         SE DECISION MADE: 29-JAN-18
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Merit Syringe
Merit Medical Systems, Inc.       510(k) NO: K173601(Abbreviated)
ATTN: Cory  Marsh                 PHONE NO : 801 3163690 
1600 W Merit Parkway              SE DECISION MADE: 31-JAN-18
South Jordan UT  84045            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optima XR240amx, AutoGrid
GE Medical Systems, LLC           510(k) NO: K173602(Traditional)
ATTN: Chris  Paulik               PHONE NO : 262 5482010 
3000 N. Grandview Blvd.           SE DECISION MADE: 12-JAN-18
Waukesha WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIP Arthrodesis System
In2Bones SAS                      510(k) NO: K173616(Traditional)
ATTN: Morgane  Grenier            PHONE NO : 
28 Chemin du Petit Bois           SE DECISION MADE: 19-JAN-18
Ecully  FR 69130                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CS Imaging
Trophy                            510(k) NO: K173622(Traditional)
ATTN: Marie-Pierre  Labat-camy    PHONE NO : 33 1 808500 
4 Rue F. Pelloutier               SE DECISION MADE: 16-JAN-18
Croissy- Beaubourg  FR 77435      510(k) STATEMENT
                                                    

DEVICE: syngo.via RT Image Suite
Siemens Medical Solutions USA, Inc510(k) NO: K173635(Traditional)
ATTN: Kimberly  Mangum            PHONE NO : 610 4486477 
40 Liberty Blvd.                  SE DECISION MADE: 12-JAN-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Activ Ankle
Newclip Technics                  510(k) NO: K173641(Traditional)
ATTN: Gaelle  Lussori             PHONE NO : 33 2 28213712 
PA de la Lande Saint Martin - 45 rSE DECISION MADE: 16-JAN-18
Haute-Goulaine  FR 44 115         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AquaShield System CO2- Fujifilm
United States Endoscopy Group, Inc510(k) NO: K173650(Special)
ATTN: Carroll  Martin             PHONE NO : 440 3586259 
5976 Heisley Road                 SE DECISION MADE: 05-JAN-18
Mentor OH  44060                  510(k) STATEMENT
                                                    

DEVICE: Juliet Ti LL
SPINEART                          510(k) NO: K173702(Special)
ATTN: Franck  Pennesi             PHONE NO : 41 22 5701200 
3 chemin du pre Fleuri            SE DECISION MADE: 03-JAN-18
Plan Les Ouates  CH 1228          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm
InNeuroCo, Inc                    510(k) NO: K173709(Special)
ATTN: Marc  Litzenberg            PHONE NO : 954 4725988 
4635 NW 103rd Avenue              SE DECISION MADE: 26-JAN-18
Sunrise FL  33351                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kinsa QuickCare Thermometer
KINSA, Inc.                       510(k) NO: K173730(Third Party - Traditional)
ATTN: David  Gal                  PHONE NO : 510 5082700 
535 Mission St, 18th Floor        SE DECISION MADE: 17-JAN-18
San Francisco CA  94105           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Thermage CPT System and Accessories
Solta Medical                     510(k) NO: K173759(Special)
ATTN: Ken  Nehmer                 PHONE NO : 510 2595299 
11720 North Creek Pkway N. Suite 1SE DECISION MADE: 08-JAN-18
Bothell WA  98011                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tempus Pro Patient Monitor
Remote Diagnostic Technologies Ltd510(k) NO: K173768(Special)
ATTN: James  Hamlyn               PHONE NO : 44 0 1256362436 
Pavilion C2, Ashwood Park, AshwoodSE DECISION MADE: 10-JAN-18
Basingstoke  GB RG23 8BG          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HI-TORQUE TurnTrac Guide Wire Family
Abbott Vascular                   510(k) NO: K173795(Special)
ATTN: Aniket  Khakhadiya          PHONE NO : 408 8458314 
3200 Lakeside Drive               SE DECISION MADE: 12-JAN-18
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DeGen Medical E3 MIS Pedicle Screw System
Degen Medical                     510(k) NO: K173814(Traditional)
ATTN: Craig  Black                PHONE NO : 843 9924551 
1321-C North Cashua Drive         SE DECISION MADE: 29-JAN-18
Florence SC  29501                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU)
Boston Scientific Corporation     510(k) NO: K173820(Special)
ATTN: Mugdha  Dongre              PHONE NO : 510 6242111 
47215 Lakeview Boulevard          SE DECISION MADE: 17-JAN-18
Femont CA  94538                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GU60A & GU60A-65
Samsung Electronics Co.,Ltd.      510(k) NO: K173828(Traditional)
ATTN: Noh  Jaesang                PHONE NO : 82 31 2001764 
129, Samsung-Ro, Yeongtong-Gu     SE DECISION MADE: 12-JAN-18
Suwon-Si  KR 16677                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIA Radiation Therapy Management
Varian Medical Systems, Inc.      510(k) NO: K173838(Special)
ATTN: Peter J. Coronado           PHONE NO : 650 4246320 
3100 Hansen Way                   SE DECISION MADE: 17-JAN-18
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: illumiflow 148 Laser Cap
EGlobal, LLC                      510(k) NO: K173843(Special)
ATTN: Wayne  De Stefano           PHONE NO : 877 3645242 
10115 E Bell Rd Suite 107         SE DECISION MADE: 26-JAN-18
Scottsdale AZ  85260              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker AIM Light Source and SafeLight cable
Stryker                           510(k) NO: K173866(Special)
ATTN: Jay  Nayar                  PHONE NO : 408 7542729 
5900 Optical Court                SE DECISION MADE: 18-JAN-18
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert
StelKast, Inc.                    510(k) NO: K173875(Special)
ATTN: Dave  Stumpo                PHONE NO : 724 7312208 
200 Hidden Valley Road            SE DECISION MADE: 19-JAN-18
McMurray PA  15317                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cybird LED Curing Light
DXM Co., Ltd                      510(k) NO: K173876(Special)
ATTN: Seung Hyun  Kim             PHONE NO : 82 31 9098275 
Baekseok-dong, Ilsan technotown 10SE DECISION MADE: 24-JAN-18
Goyang-si  KR 411-360             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PreXion3D Excelsior
PreXion Corporation               510(k) NO: K173878(Special)
ATTN: Katsumi  Hayashi            PHONE NO : 81 3 52977551 
1-14-1 Kandasuda-cho              SE DECISION MADE: 19-JAN-18
Chiyoda-ku  JP 101-0041           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unity Total Knee System
Corin USA Limited                 510(k) NO: K173884(Traditional)
ATTN: Lorraine  Mander            PHONE NO : 813 9774469 
12750 Citrus Park Lane            SE DECISION MADE: 17-JAN-18
Tampa FL  33625                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume
Vascular Solutions, Inc.          510(k) NO: K173891(Special)
ATTN: Lisa  Gallatin              PHONE NO : 763 6564300 
6464 Sycamore Court N             SE DECISION MADE: 19-JAN-18
Minneapolis MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2
Alere Scarborough, Inc.           510(k) NO: K173932(Special)
ATTN: Angela  Drysdale            PHONE NO : 207 4151393 
10 Southgate Road                 SE DECISION MADE: 26-JAN-18
Scarborough ME  04074             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uDR 780i
Shanghai United Imaging Healthcare510(k) NO: K173953(Traditional)
ATTN: Xin  GAO                    PHONE NO : 86 21 67076888 5386
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 26-JAN-18
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mic-Key* SF Over-the-Wire Stoma Measuring Device
Halyard Health, Inc.              510(k) NO: K173955(Special)
ATTN: David M Lee                 PHONE NO : 470 4485182 
5405 Windward Parkway             SE DECISION MADE: 26-JAN-18
Alpharetta GA  30004              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AtriClip FLEX-V
AtriCure, Inc.                    510(k) NO: K180010(Special)
ATTN: Brittany  Lowe              PHONE NO : 513 7555652 
7555 Innovation  Way              SE DECISION MADE: 31-JAN-18
Mason OH  45040                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Centurion POCT System
Orthofix Inc.                     510(k) NO: K180025(Special)
ATTN: Jacki  Koch                 PHONE NO : 214 9372100 
3451 Plano Parkway                SE DECISION MADE: 22-JAN-18
Lewisville TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    


         TOTAL 510(k)s THIS PERIOD   234                                     
         TOTAL WITH SUMMARIES        224                                     
         TOTAL WITH STATEMENTS        10
                                      

Page Last Updated: 03/22/2018
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