510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD February 2020
DEVICE: Infinity / Infinity Cross Flex Dental Systems
Olsen Insdustria de Equipamentos O510(k) NO: K180935(Traditional)
ATTN: Ana Claudia Espindola PHONE NO : 55 19 38179633
Av. Ivo Luchi, 68 - Jardim EldoradSE DECISION MADE: 05-FEB-20
Palhoça - BR 88133-510 510(k) STATEMENT
DEVICE: Pulmonary Cytology Brush
Hobbs Medical, Inc. 510(k) NO: K182927(Traditional)
ATTN: Carlos O. Acosta PHONE NO : 860 8519842
8 Spring Street SE DECISION MADE: 07-FEB-20
Stafford Springs CT 06076 510(k) STATEMENT
DEVICE: Implacil Implant System
Implacil de Bortoli Material Odont510(k) NO: K183024(Traditional)
ATTN: Thiago Toni PHONE NO : 55 11 33425100
Rua Vicente de Carvalho 178-182 SE DECISION MADE: 13-FEB-20
Sao Paulo BR 01521020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OKLand Patient Return Electrode Pad
Auckland Medical Polymer(Tianjin) 510(k) NO: K183148(Traditional)
ATTN: Bei Lei Gao PHONE NO : 86 151 22456760
Building D5-2, XEDA International SE DECISION MADE: 04-FEB-20
Tianjin CN 300385 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott point of Care, Inc. 510(k) NO: K183678(Traditional)
ATTN: Susan Tibedo PHONE NO : 609 4549360
400 College Road East SE DECISION MADE: 07-FEB-20
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care Inc. 510(k) NO: K183680(Traditional)
ATTN: Susan Tibedo PHONE NO : 609 4549360
400 College Road East SE DECISION MADE: 28-FEB-20
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc. 510(k) NO: K183688(Traditional)
ATTN: Susan Tibedo PHONE NO : 609 4549360
400 College Road East SE DECISION MADE: 07-FEB-20
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Sclerotherapy Needle
Hangzhou AGS MedTech CO., Ltd 510(k) NO: K190032(Traditional)
ATTN: Xiangyong Yu PHONE NO : 86 571 87671223
Building 5, Building 6, Kangxin RoSE DECISION MADE: 27-FEB-20
Hangzhou CN 310000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K3Pro Konus New Abutments and Implants
Argon Med. Productions Vertriebs G510(k) NO: K190192(Traditional)
ATTN: Richard Donaca PHONE NO : 49 6721 30960
Franz-Kirsten-Str. 1 SE DECISION MADE: 10-FEB-20
Bingen Am Rhein DE 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vesta RF Cannula
Biomerics 510(k) NO: K190259(Special)
ATTN: Jake Wakley PHONE NO : 801 3552705
6030 West Harold Gatty Drive SE DECISION MADE: 07-FEB-20
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kingon P2 Oxygen Concentrator
Qingdao Kingon Medical Science and510(k) NO: K190304(Traditional)
ATTN: Roman Huang PHONE NO : 532 86767095
24th East Building, No. 252 Yanhe SE DECISION MADE: 29-FEB-20
Qingdao CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage
Omnia Medical, LLC 510(k) NO: K190363(Traditional)
ATTN: Troy Schifano PHONE NO : 304 4134851
6 Canyon Rd Suite 300 SE DECISION MADE: 21-FEB-20
Morgantown WV 26508 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SDS2.2 dental implant
SDS Swiss Dental Solutions AG 510(k) NO: K190406(Traditional)
ATTN: Martin Chares PHONE NO : 41 715 563670
Konstanzerstrasse 11 SE DECISION MADE: 20-FEB-20
Kreuzlingen CH 8280 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InPen Dose Calculator
Companion Medical, Inc. 510(k) NO: K190487(Traditional)
ATTN: Jasper Benke PHONE NO : 858 5220252
11011 Via Frontera, Suite D SE DECISION MADE: 18-FEB-20
San Diego CA 92127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AR_N SLA Type Implant System
Biotem Co., Ltd. 510(k) NO: K190641(Traditional)
ATTN: Hong Koo Yeo PHONE NO : 82 70 82204934
422 Sasang-ro, Sasang-gu SE DECISION MADE: 21-FEB-20
Busan KR 46925 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Explorer Mini
Permobil AB 510(k) NO: K190682(Traditional)
ATTN: Ivan Fernandez PHONE NO : 800 7360925
Box 120 S-861 23 SE DECISION MADE: 27-FEB-20
Timra SE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors
Cosmed Srl 510(k) NO: K190800(Traditional)
ATTN: Andrea Duca PHONE NO : 39 06 9315492
Vi dei Piani di Monte Savello 37, SE DECISION MADE: 06-FEB-20
Rome IT 0041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flowart
ASSET MEDIKAL TASARIM A.S. 510(k) NO: K190806(Traditional)
ATTN: Ebru Sirali PHONE NO : 902 124942727
Marmara San. Sit. M Blok No: 7-A, SE DECISION MADE: 20-FEB-20
Istanbul TR 34303 510(k) STATEMENT
DEVICE: Comus Locking Plate systems
Jiangsu Trauhui Medical Instrument510(k) NO: K190842(Traditional)
ATTN: Zhou Yu PHONE NO : 086 519 88769966
No.2 Longqing Road, Wujin Hi-Tech SE DECISION MADE: 03-FEB-20
Changzhou CN 213168 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XenoSure Biologic Patch
LeMaitre Vascular 510(k) NO: K190882(Traditional)
ATTN: John N. Bradsher PHONE NO : 781 4251685
63 Second Avenue SE DECISION MADE: 13-FEB-20
Burlington MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArtiSential Bipolar Fenestrated Forceps
Livsmed Inc. 510(k) NO: K190909(Traditional)
ATTN: Dong Wook Lee PHONE NO : 82 70 42827652
#304, D-dong, 700, Pangyo-ro, BundSE DECISION MADE: 13-FEB-20
Seongnam-si KR 13516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ST Internal Implant System
T-Plus Implant Tech. Co., Ltd. 510(k) NO: K190919(Traditional)
ATTN: Dana Cheng PHONE NO : 886 2 22981950
No.41, Wuquan 6th Rd., Wugu Dist. SE DECISION MADE: 27-FEB-20
New Taipei County TW 24889 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bella-mu
U-Needle B.V. 510(k) NO: K190962(Traditional)
ATTN: Gert Veldhuis PHONE NO : 31 6 43010203
De Veldmaat 10 SE DECISION MADE: 03-FEB-20
Enschede NL 7522 NM 510(k) STATEMENT
DEVICE: Katalyst Training System
Katalyst Inc. 510(k) NO: K190966(Traditional)
ATTN: Bjoern Woltermann PHONE NO : 206 4883939
316 Occidental Ave. South Suite B3SE DECISION MADE: 03-FEB-20
Seattle WA 98104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer
Life Technologies Corporation 510(k) NO: K191030(Traditional)
ATTN: Darcie Baynes PHONE NO : 858 8372891
5781 Van Allen Way SE DECISION MADE: 21-FEB-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPENERGY - C100, C200, C300, C400, C50
Capenergy Medical SL 510(k) NO: K191202(Traditional)
ATTN: Pilar Sanchez PHONE NO : 0034 93 4774348
Avinguda Mare de Deu de MontserratSE DECISION MADE: 11-FEB-20
Sant Joan Despi, Barcelona ES 089510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Leltek Ultrasound Imaging System
Leltek Inc 510(k) NO: K191235(Traditional)
ATTN: Kiefe Chang PHONE NO : 886 2 29137577
6F-3., No. 293, Sec. 1, Beixin Rd.SE DECISION MADE: 12-FEB-20
New Taipei City TW 23147 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)
Chalice Medical Ltd 510(k) NO: K191246(Traditional)
ATTN: Carol Middleton PHONE NO : 44 1909 470777
Manton Wood Enterprise Park, SE DECISION MADE: 28-FEB-20
Worksop GB S80 2RS 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ancora Nerve Block Catheter Set
Ancora Medical Technology 510(k) NO: K191290(Traditional)
ATTN: Chunyuan Qiu PHONE NO : 650 8592203
333 Ravenswood Ave SE DECISION MADE: 06-FEB-20
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care Inc. 510(k) NO: K191298(Traditional)
ATTN: Susan Tibedo PHONE NO : 609 4549360
400 College Road East SE DECISION MADE: 07-FEB-20
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unity Subcutaneous Infusion System for Remodulin
DEKA Research & Development 510(k) NO: K191313(Traditional)
ATTN: Jason Demers PHONE NO : 603 6695139
340 Commercial Street SE DECISION MADE: 21-FEB-20
Manchester NH 03101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
Blackrock Microsystems 510(k) NO: K191346(Traditional)
ATTN: Rachelle Frischknecht PHONE NO : 801 5825533
630 Komas Drive, Suite 200 SE DECISION MADE: 14-FEB-20
Salt Lake City UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Paragon XHD Diagnostic Ultrasound System
Shenzhen Wisonic Medical Technolog510(k) NO: K191347(Traditional)
ATTN: Jiang Xiaosan PHONE NO : 8675 5860 077888087
1st, 2nd & 5th Floor, No. 6 BuildiSE DECISION MADE: 07-FEB-20
Shenzhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc. 510(k) NO: K191360(Traditional)
ATTN: Susan Tibedo PHONE NO : 609 4549360
400 College Road East SE DECISION MADE: 14-FEB-20
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01
Fujimori Kogyo Co., Ltd. 510(k) NO: K191364(Traditional)
ATTN: Jeffrey Dahlen PHONE NO : 619 7420203
Shinjuku First West 1-23-7 Nishi-SSE DECISION MADE: 14-FEB-20
Shinjuku, Tokyo JP 160-0023 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Allcem Veneer APS
Dentscare Ltda 510(k) NO: K191389(Traditional)
ATTN: Roberta Uyara PHONE NO : 55 47 34416131
Av. Edgar Nelson Meister, 474 SE DECISION MADE: 25-FEB-20
Joinville BR 89219-501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Heater-Cooler System 3T
LivaNova Deutschland GmbH 510(k) NO: K191402(Traditional)
ATTN: Scott Light PHONE NO : 49 89 323010
Lindberghstrasse 25 SE DECISION MADE: 25-FEB-20
Munich DE 80939 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Novalung System
Fresenius Medical Care Renal Thera510(k) NO: K191407(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 9969103
920 Winter Street SE DECISION MADE: 21-FEB-20
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ah!Yes Ob Coco Personal Lubricant
Bio-Tech Lubricants Ltd 510(k) NO: K191411(Traditional)
ATTN: Sarah Brooks PHONE NO : 44 0 3450941141
C/O Epsilon House, Enterprise RoadSE DECISION MADE: 06-FEB-20
Southampton GB SO16 7NS 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack
Caldera Medical, Inc. 510(k) NO: K191416(Traditional)
ATTN: Vicki Gail PHONE NO : 818 4837602
5171 Clareton Drive SE DECISION MADE: 07-FEB-20
Agoura Hills CA 91301 510(k) STATEMENT
DEVICE: Cervitec F
Ivoclar Vivadent, AG 510(k) NO: K191453(Traditional)
ATTN: Sandra Cakebread PHONE NO : 423 235 3535
Bendererstrasse 2 SE DECISION MADE: 11-FEB-20
Schaan LI FL-9494 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Proov Test
MFB Fertility, Inc. 510(k) NO: K191462(Traditional)
ATTN: Amy Beckley PHONE NO :
999 Sumner Way SE DECISION MADE: 27-FEB-20
Erie CO 80516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Synthes Hammertoe Continuous Compression Implant
Synthes (USA) Products, LLC 510(k) NO: K191463(Traditional)
ATTN: Keith Knapp PHONE NO : 610 7195942
1301 Goshen Parkway SE DECISION MADE: 26-FEB-20
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)
Fresenius Medical Care Renal Thera510(k) NO: K191474(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 9969103
920 Winter Street SE DECISION MADE: 24-FEB-20
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CareStart Flu A&B Plus
Access Bio, Inc. 510(k) NO: K191514(Dual Track)
ATTN: Sang Joon Han PHONE NO : 732 8734040
65 Clyde Road, Suite A. SE DECISION MADE: 18-FEB-20
Somerset NJ 08873 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci Xi Surgical System, da Vinci X Surgical System
Intuitive Surgical 510(k) NO: K191529(Traditional)
ATTN: Brandon Hansen PHONE NO : 408 7182059
1266 Kifer Road SE DECISION MADE: 06-FEB-20
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Caterpillar and Caterpillar Micro Arterial Embolization Devices
C. R. Bard, Inc. 510(k) NO: K191532(Traditional)
ATTN: Melanie Hadlock PHONE NO : 480 3506083
Moyne Upper SE DECISION MADE: 04-FEB-20
Emniscorthy IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biatain Silicone Ag
Coloplast A/S 510(k) NO: K191536(Traditional)
ATTN: Kimberly Tokach PHONE NO : 612 7592205
Holtedam 1 SE DECISION MADE: 21-FEB-20
Humlebaek DK 3050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length
Ethicon Endo-Surgery, LLC 510(k) NO: K191555(Traditional)
ATTN: Nathan Anderson PHONE NO : 787 2726144
475 Calle C SE DECISION MADE: 28-FEB-20
Guaynabo PR 00969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Red Dot
Behold.AI Technologies Limited 510(k) NO: K191556(Traditional)
ATTN: Simon Rasalingham PHONE NO :
91-97 Bohemia Road SE DECISION MADE: 28-FEB-20
St. Leonards-On-Sea GB TN37 6RJ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UV Radiation Treatment System
Xuzhou Yongkang Electronic Science510(k) NO: K191571(Traditional)
ATTN: Kai Li PHONE NO : 86 516 87892766 601
4F Building C8, 40 Jingshan Road, SE DECISION MADE: 06-FEB-20
Xuzhou CN 221000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Beamscan MR
PTW-Freiburg Physikalisch-Technisc510(k) NO: K191646(Traditional)
ATTN: Sandor-Csaba Ats PHONE NO : 49 761 49055896
Dr. Pychlau GmbH Loerracher Str. 7SE DECISION MADE: 21-FEB-20
Freiburg DE 79115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EleGARD Patient Positioning System
Minnesota Resuscitation Solutions,510(k) NO: K191689(Traditional)
ATTN: Philip Tetzlaff PHONE NO : 763 2593722
5201 Eden Ave., Suite 300 SE DECISION MADE: 13-FEB-20
Edina MN 55436 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cardiac Monitor 1500
Zynex Medical, Inc. 510(k) NO: K191697(Traditional)
ATTN: Thomas Sandgaard PHONE NO : 303 7034906
9995 Maroon Circle SE DECISION MADE: 21-FEB-20
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-MIND Trium
de Gotzen S.R.L 510(k) NO: K191719(Traditional)
ATTN: Dario Bandiera PHONE NO : 39 0331 376760
via Roma, 45 SE DECISION MADE: 20-FEB-20
Olgiate Olona IT 21057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTepap Expiratory Positive Airway Pressure (EPAP) Device
Bryggs Medical, LLC 510(k) NO: K191728(Traditional)
ATTN: Geoffrey Sleeper PHONE NO : 216 8706990
34910 Commerce Way SE DECISION MADE: 21-FEB-20
Avon OH 44011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Graft Bone Substitute
Purgo Biologics Inc. 510(k) NO: K191737(Traditional)
ATTN: Eun Ho Kim PHONE NO : 82 2 5494635
E-607, 700, Pangyo-ro Bundang-gu SE DECISION MADE: 14-FEB-20
Seongnam-si KR 13516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORO LUCENT® iXI and iMRI Headrest System
Pro Med Instruments GmbH 510(k) NO: K191740(Traditional)
ATTN: Sandra Untenberger PHONE NO : 49 076 138422210
Boetzinger Str. 38 SE DECISION MADE: 21-FEB-20
Freiburg DE 79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Orion LifeSpan MEG
Compumedics Limited 510(k) NO: K191785(Traditional)
ATTN: William Alam PHONE NO : 61 3 84207300
30-40 Flockhart Street SE DECISION MADE: 14-FEB-20
Abbotsford AU 3067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vathin Video Bronchoscope System
Hunan Vathin Medical Instrument Co510(k) NO: K191828(Traditional)
ATTN: Yun Feng PHONE NO : 86 180 17856052
1/F, Building 12, No 9 Chuanqi wesSE DECISION MADE: 13-FEB-20
Xiangtan CN 411100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microlife Non-Contact Infrared Forehead Thermometer
Microlife Intellectual Property Gm510(k) NO: K191829(Traditional)
ATTN: Gerhard Frick PHONE NO : 41 717 277000
Espenstrasse 139 SE DECISION MADE: 13-FEB-20
Widnau CH 9443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)
Kurin, Inc 510(k) NO: K191832(Traditional)
ATTN: Neal Hartman PHONE NO : 888 9639056
10840 Thornmint Road, Suite 111 SE DECISION MADE: 04-FEB-20
San Diego CA 92127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pylant Monitor
Kal-Med LLC 510(k) NO: K191858(Traditional)
ATTN: Sandra Greenwood PHONE NO : 585 6334225
570 Percival Avenue SE DECISION MADE: 24-FEB-20
Kensington CT 06037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elos Accurate Customized Abutment
Elos Medtech Pinol A/S 510(k) NO: K191890(Traditional)
ATTN: Tina Friis Poulsen PHONE NO : 004 548 216469
Engvej 33 SE DECISION MADE: 06-FEB-20
Goerloese DK DK-3330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Upper Arm Blood Pressure Monitor
ShenZhen ZhengKang Technology Co.,510(k) NO: K191894(Traditional)
ATTN: Huayong Yang PHONE NO : 86 755 883260864
3/F, Building A, No. 3 FuXing Yi LSE DECISION MADE: 21-FEB-20
ShenZhen City CN 518100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elos Accurate Hybrid Base
Elos Medtech Pinol A/S 510(k) NO: K191919(Traditional)
ATTN: Tina Friis Poulsen PHONE NO : 45 4821 6400
Engvej 33 SE DECISION MADE: 10-FEB-20
Gorlose DK DK-3330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccuContour
Xiamen Manteia Technology LTD. 510(k) NO: K191928(Traditional)
ATTN: Lu Xie PHONE NO : 86 592 6100813
1903, B Tower, Zijin Plaza, No.181SE DECISION MADE: 28-FEB-20
Xiamen CN 361001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Penumbra System Penumbra JET 7X
Penumbra, Inc. 510(k) NO: K191946(Traditional)
ATTN: Micaela Victoria PHONE NO : 510 9952082
One Penumbra Place SE DECISION MADE: 27-FEB-20
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NewPrim System
BRM Extremities 510(k) NO: K191966(Traditional)
ATTN: Andrea De Maglio PHONE NO : 389 1938034
Via Ciro Menotti 10 SE DECISION MADE: 13-FEB-20
Milano MI 20129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elefix V Paste for EEG & EMG
Nihon Kohden Corporation 510(k) NO: K191975(Traditional)
ATTN: Sandra Gadeyne PHONE NO : 949 6809048
1-31-4 Nishiochiai, Shinjuku-ku SE DECISION MADE: 07-FEB-20
Tokyo JP 161-8560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D R Burton OxyPAP
D R Burton Healthcare, LLC 510(k) NO: K192000(Traditional)
ATTN: Dennis Cook PHONE NO : 252 2287038
3936 S Fields St SE DECISION MADE: 19-FEB-20
Farmville NC 27828 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lucy Point-of-Care Magnetic Resonance Imaging Device
Hyperfine Research, Inc. 510(k) NO: K192002(Traditional)
ATTN: Brian Sawin PHONE NO :
530 Old Whitfield Street SE DECISION MADE: 06-FEB-20
Guilford CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DiaTemp Flow
Diadent Group International 510(k) NO: K192022(Traditional)
ATTN: Kab Sun Lee PHONE NO : 82 43 2662315
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 13-FEB-20
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tina-quant C-Reactive Protein IV
Roche Diagnostics Operations (RDO)510(k) NO: K192072(Traditional)
ATTN: Barbara Ann McWhorter PHONE NO : 317 5212336
9115 Hague Rd SE DECISION MADE: 21-FEB-20
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omnia Medical Trauma Screws
Omnia Medical, LLC 510(k) NO: K192096(Traditional)
ATTN: Troy Schifano PHONE NO : 304 4134851
6 Canyon Rd Suite 300 SE DECISION MADE: 27-FEB-20
Morgantown WV 26508 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm
Venner Medical (Singapore) Pte Ltd510(k) NO: K192120(Traditional)
ATTN: Adrian P Waterton PHONE NO : 65 6511 2350
35 Joo Koon Circle SE DECISION MADE: 14-FEB-20
Singapore SG 629110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Respire Pink AT (Hard, Hard/Soft, EF)
Respire Medical Holdings 510(k) NO: K192127(Special)
ATTN: Madubuike Okafor PHONE NO : 718 3609209
18 Bridge St. Suite 3J SE DECISION MADE: 05-FEB-20
Brooklyn NY 11201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Maximus System
Hill-Rom Services Pte Ltd 510(k) NO: K192143(Traditional)
ATTN: Alvin Tan PHONE NO : 65 6499 7391
1 Yishun Ave 7 SE DECISION MADE: 14-FEB-20
Singapore SG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DiaTemp
Diadent Group International 510(k) NO: K192158(Traditional)
ATTN: Kab Sun Lee PHONE NO : 82 4326 62315
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 13-FEB-20
Cheongji-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acteon Imaging Suite
de Gotzen S.R.L 510(k) NO: K192165(Traditional)
ATTN: Dario Bandiera PHONE NO : 39 0331 376760
via Roma, 45 SE DECISION MADE: 11-FEB-20
Olgiate Olona IT 21057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VSP System
3D Systems 510(k) NO: K192192(Traditional)
ATTN: Kim Torluemke PHONE NO : 720 6431001
5381 South Alkire Circle SE DECISION MADE: 26-FEB-20
Littleton CO 80127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JO for Him H2O Gel Original Personal Lubricant
United Consortium 510(k) NO: K192203(Traditional)
ATTN: Stephanie Morris PHONE NO : 661 2951700
29000 N. Hancock Pkwy. SE DECISION MADE: 10-FEB-20
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LED Curing Light
Foshan CICADA Dental Instrument Co510(k) NO: K192233(Traditional)
ATTN: Juan Liu PHONE NO : 86 757 85775667
B5-2F, Guangdong New Light Source SE DECISION MADE: 13-FEB-20
Foshan CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Steripath Gen2 Blood Collection System
Magnolia Medical Technologies, Inc510(k) NO: K192247(Traditional)
ATTN: Gregory J Bullington PHONE NO : 1 206 3691319
200 West Mercer Street Suite 500 SE DECISION MADE: 28-FEB-20
Seattle WA 98119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SonicEye Dual-Array Ultrasound System
Sonivate Medical Inc 510(k) NO: K192253(Traditional)
ATTN: Steve Hesler PHONE NO : 503 2608221
4640 SW Macadam Ave. Suite 200 SE DECISION MADE: 25-FEB-20
Portland OR 97239 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UCLA CCM Abutment
DIO Corporation 510(k) NO: K192263(Traditional)
ATTN: Jiae Park PHONE NO : 82 51 7457836
66, Centum Seo-ro, Haeundae-gu SE DECISION MADE: 21-FEB-20
Busan KR 48058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit
Diadent Group International 510(k) NO: K192273(Traditional)
ATTN: Kab Sun Lee PHONE NO : 82 43 2662315
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 07-FEB-20
Cheongu-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CardIQ Flow
GE Medical Systems SCS 510(k) NO: K192277(Traditional)
ATTN: Elizabeth Mathew PHONE NO : 262 4247774
283 rue de la Miniere SE DECISION MADE: 14-FEB-20
Buc FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Colibri Endoscopy System
3NT Medical Ltd. 510(k) NO: K192305(Special)
ATTN: Ehud Bendory PHONE NO : 972 73 7154056
22 HaMelacha St., POB 11384 SE DECISION MADE: 27-FEB-20
Rosh Ha’Ayin IL 4809169 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: scaffolene CL100 Bioresorbable Collagen Matrix
Freudenberg Technology Innovation 510(k) NO: K192346(Traditional)
ATTN: Denis Reibel PHONE NO : 49 6201 806357
Hoehnerweg 2-4 SE DECISION MADE: 28-FEB-20
Weinheim DE 69469 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCEND Image Viewer
Ascend Hit 510(k) NO: K192372(Traditional)
ATTN: Andy Miller PHONE NO : 1 224 7650885
801 Warrenville Road Ste 200 SE DECISION MADE: 14-FEB-20
Lisle IL 60532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon
Varian Medical Systems, Inc. 510(k) NO: K192377(Traditional)
ATTN: Peter J Coronado PHONE NO : 650 4246320
911 Hansen Way SE DECISION MADE: 10-FEB-20
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor
Scientifica Pharmaceuticals 510(k) NO: K192381(Traditional)
ATTN: Thomas Kelly PHONE NO : 909 5959922
3221 Producer Way SE DECISION MADE: 18-FEB-20
Pmona CA 91768 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Praxiject 0.9% NaCl
MedXL Inc. 510(k) NO: K192414(Special)
ATTN: Premala Premanathan PHONE NO : 1 514 6957474
285 Av Labrosse SE DECISION MADE: 13-FEB-20
Pointe-Claire CA H9R 1A3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Superelastic Staple
Neosteo 510(k) NO: K192447(Traditional)
ATTN: Anne-Cecile Grandremy PHONE NO : 33 23656 9670
Malleve 2A, 1 Boulevard Jean MouliSE DECISION MADE: 28-FEB-20
Nantes FR 44 100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sentinel Cerebral Protection System
Boston Scientific Corporation 510(k) NO: K192460(Special)
ATTN: Eric Elliott PHONE NO : 763 4942081
Three Scimed Place SE DECISION MADE: 19-FEB-20
Maple Grove MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Coolief Radiofrequency Generator (CRG) System
Avanos Medical, Inc. 510(k) NO: K192491(Traditional)
ATTN: Thomas Kozma PHONE NO : 844 4282667
5405 Windward Parkway, Suite 100 SE DECISION MADE: 21-FEB-20
Alpharetta GA 30004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magnetom Sola, Magnetom Altea and Magnetom Sola Fit
Siemens Medical Solutions USA Inc.510(k) NO: K192496(Traditional)
ATTN: Cordell L Fields PHONE NO : 610 4486469
40 Liberty Boulevard, Mail Code 65SE DECISION MADE: 28-FEB-20
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rochal Antimicrobial Wound Gel
Rochal Industries, LLC 510(k) NO: K192527(Traditional)
ATTN: William J. Coulston PHONE NO : 210 3759349
12000 Network Blvd, Ste B200 SE DECISION MADE: 07-FEB-20
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Potenza
Jeisys Medical Incorporated 510(k) NO: K192545(Traditional)
ATTN: Wonchel Choi PHONE NO : 82 707435 4626
307 Daeyung Techno Town 8th; GamasSE DECISION MADE: 20-FEB-20
Seoul KR 08501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Youjia Unscented Tampon with Plastic Applicators
Qingdao Youjia Hygiene Technology 510(k) NO: K192557(Special)
ATTN: Huiying Zhao PHONE NO : 86 532 86613616
No. 778 Mingyue Road, Huangdao ZonSE DECISION MADE: 13-FEB-20
Qingdao CN 266400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atlas Spine Expandable Cervical Standalone Interbody System
Atlas Spine, Inc. 510(k) NO: K192570(Traditional)
ATTN: Thomas Smith PHONE NO : 561 7411108
1555 Jupiter Park Drive, Suite 1 SE DECISION MADE: 28-FEB-20
Jupiter FL 33458 510(k) STATEMENT
DEVICE: X-Guide Surgical Navigation System
X-Nav Technologies, LLC 510(k) NO: K192579(Traditional)
ATTN: Fred Cowdery PHONE NO : 267 4360414
1555 Bustard Road, Suite 75 SE DECISION MADE: 03-FEB-20
Lansdale PA 19446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULab Systems Dental Aligner Kit
uLab Systems, Inc. 510(k) NO: K192596(Traditional)
ATTN: Charlie Wen PHONE NO : 650 8041397
6 Lagoon Drive, Suite 180 SE DECISION MADE: 11-FEB-20
Redwood City CA 94065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60
quanta system spa 510(k) NO: K192600(Special)
ATTN: Francesco Dell'Antonio PHONE NO : 39 0331 376797
via Acquedotto 109 SE DECISION MADE: 21-FEB-20
Samarate (Va) IT 21017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment
MegaGen Implant CO., Ltd. 510(k) NO: K192614(Traditional)
ATTN: You Jung Kim PHONE NO : 82 53 2222991
45, Secheon-ro, 7-gil, Dasa-eup, DSE DECISION MADE: 13-FEB-20
Daegu KR 42921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gemini 810+980 Soft Tissue Laser
Azena Medical, LLC 510(k) NO: K192617(Traditional)
ATTN: Lindsay Tilton PHONE NO : 800 4665273
3021 Citrus Circle Ste 180 SE DECISION MADE: 20-FEB-20
Walnut Creek CA 94598 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pitkar Locked Plating System
S H Pitkar Orthotools Pvt Ltd. 510(k) NO: K192619(Traditional)
ATTN: Vivek Mangalwedhekar PHONE NO : 91 204 0706464
Plot No. EL 32, J Block, MIDC BhosSE DECISION MADE: 27-FEB-20
Pune IN 411026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ApneaTrak
Cadwell Industries, Inc. 510(k) NO: K192624(Traditional)
ATTN: James Blevins PHONE NO : 509 7356481
909 N. Kellogg Street SE DECISION MADE: 20-FEB-20
Kennewick WA 99336 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zimmer M/L Taper Hip Prosthesis
Zimmer, Inc. 510(k) NO: K192660(Traditional)
ATTN: Caleb Barylski PHONE NO : 574 3710250
1800 W. Center Street SE DECISION MADE: 28-FEB-20
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CapsoCam Plus (SV-3) Capsule Endoscopy System
CapsoVision, Inc. 510(k) NO: K192662(Traditional)
ATTN: Azimun Jamal PHONE NO : 408 6241488
18805 Cox Avenue Suite 250 SE DECISION MADE: 14-FEB-20
Saratoga CA 95070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mixing and Delivery System
Bone Solutions, Inc. 510(k) NO: K192674(Traditional)
ATTN: Drew Diaz PHONE NO : 817 8098850
5712 Colleyville Blvd, STE 210 SE DECISION MADE: 18-FEB-20
Colleyville TX 76034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safety Insulin Pen Needle
Jiangsu Caina Medical Co., Ltd. 510(k) NO: K192677(Traditional)
ATTN: Jianwei Pan PHONE NO : 86 510 86866666 8027
No.3, Huanxi Road, Zhutang Town SE DECISION MADE: 18-FEB-20
Jiangyin CN 214415 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads
Biomet UK Ltd. 510(k) NO: K192683(Traditional)
ATTN: Lisa Ingram PHONE NO : 44 1656 655221
Waterton Industrial Estate SE DECISION MADE: 27-FEB-20
Bridgend GB CF31 3XA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: s-Clean SQ-SL Implant System Regular
Dentis Co., Ltd. 510(k) NO: K192688(Traditional)
ATTN: Gyu Ri Kim PHONE NO : 82 53 5893541
99, Seongseoseo-ro, Dalseo-gu SE DECISION MADE: 04-FEB-20
Daegu KR 42718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PatCom Single-Use Introducer
H&A Mui Enterprises Inc. 510(k) NO: K192691(Traditional)
ATTN: Tammy Mui PHONE NO : 905 890 5525
145 Traders Blvd. E., Unit #34 SE DECISION MADE: 21-FEB-20
Mississauga CA L4Z 3L3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dermadry
Dermadry Laboratories inc. 510(k) NO: K192749(Traditional)
ATTN: Maxime Calouche PHONE NO : 1 514 9039897
9223 Langelier Blvd SE DECISION MADE: 10-FEB-20
Montreal CA H1P 3K9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquadex FlexFlow System 2.0
CHF Solutions, Inc. 510(k) NO: K192756(Traditional)
ATTN: Dawn Li PHONE NO : 952 5636278
12988 Valley View Road SE DECISION MADE: 24-FEB-20
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20
VitalConnect, Inc. 510(k) NO: K192757(Traditional)
ATTN: Cynthia Merrell PHONE NO : 1 408 9634600
224 Airport Parkway, Suite 300 SE DECISION MADE: 06-FEB-20
San Jose CA 95110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OptiScanner® 5000 Glucose Monitoring System
Optiscan Biomedical Corporation 510(k) NO: K192785(Traditional)
ATTN: Charles Zimliki PHONE NO : 240 3506690
24590 Clawiter Road SE DECISION MADE: 05-FEB-20
Hayward CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Glenoid Baseplate with Screw
FX Shoulder USA, Inc. 510(k) NO: K192799(Traditional)
ATTN: Kathy Trier PHONE NO : 800 2800775
13465 Midway Road, Suite 101 SE DECISION MADE: 21-FEB-20
Dallas TX 75244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm
Medos International SARL 510(k) NO: K192804(Traditional)
ATTN: Michael Liao PHONE NO : 510 7705376
Chemin-Blanc 38 SE DECISION MADE: 27-FEB-20
Le Locle Neuchatel CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTCA Crown and Bridge
Dentca, Inc. 510(k) NO: K192806(Traditional)
ATTN: Jason Lee PHONE NO : 424 5588726
357 Van Ness Way #250 SE DECISION MADE: 05-FEB-20
Torrance CA 90501 510(k) STATEMENT
DEVICE: SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)
Medline Industries, Inc. 510(k) NO: K192820(Traditional)
ATTN: Matt Clausen PHONE NO : 847 6434785
Three Lakes Drive SE DECISION MADE: 28-FEB-20
Northfield IL 60093 510(k) STATEMENT
DEVICE: Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System
Canon Medical Systems Corporation 510(k) NO: K192828(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 13-FEB-20
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
Canon Medical Systems Corporation 510(k) NO: K192832(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 21-FEB-20
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InPen System
Companion Medical, Inc. 510(k) NO: K192841(Traditional)
ATTN: Jasper Benke PHONE NO : 858 5220252
11011 Via Frontera, Suite D SE DECISION MADE: 10-FEB-20
San Diego CA 92127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Argen Clear Aligner, Argen Clear Aligner Premium
Argen Corporation 510(k) NO: K192846(Special)
ATTN: Paul Cascone PHONE NO : 858 6268612
5855 Oberlin Drive SE DECISION MADE: 10-FEB-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OASIS MRI System
Hitachi Healthcare Americas 510(k) NO: K192851(Traditional)
ATTN: Aaron Pierce PHONE NO : 330 4251313
1959 Summit Commerce Park SE DECISION MADE: 21-FEB-20
Twinsburg OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELTA XTEND(TM) Reverse Shoulder System
DePuy (Ireland) 510(k) NO: K192855(Traditional)
ATTN: Ashley Goncalo PHONE NO : 508 9773907
Loughbeg Ringaskiddy SE DECISION MADE: 24-FEB-20
County Cork IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELLIO Tablet Application
Smith & Nephew 510(k) NO: K192876(Traditional)
ATTN: Janice Haselton PHONE NO : 978 7491494
150 Minuteman Rd SE DECISION MADE: 27-FEB-20
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vita Flex CR System with LLI
Carestream Health, Inc. 510(k) NO: K192894(Special)
ATTN: Duane Gutowski PHONE NO : 585 6278760
150 Verona Street SE DECISION MADE: 18-FEB-20
Rochester NY 14608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PneumoLiner
Advanced Surgical Concepts 510(k) NO: K192898(Traditional)
ATTN: Edward Hyland PHONE NO : 353 1 2864777
Unit 4, Sunnybank Center, Upper DaSE DECISION MADE: 25-FEB-20
Bray IE A98 E339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Video Laparoscope, Video Processor, Light Source
FUJIFILM Corporation 510(k) NO: K192918(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 20-FEB-20
Ashigarakami-Gun JP 2588538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
Gentuity, LLC 510(k) NO: K192922(Traditional)
ATTN: David Kolstad PHONE NO : 978 2024108 203
142 North Road, Suite G SE DECISION MADE: 20-FEB-20
Sudbury MA 01776 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vitrea Software Package
Canon Medical Systems Corporation 510(k) NO: K192923(Traditional)
ATTN: Paul Biggins PHONE NO : 81 287 266478
1385 Shimoishigami SE DECISION MADE: 14-FEB-20
Otawara JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: icobrain-ctp
Icometrix NV 510(k) NO: K192962(Traditional)
ATTN: Dirk Smeets PHONE NO : 32 1636 9000
Kolonel Begaultlaan 1b/12 SE DECISION MADE: 28-FEB-20
Leuven BE 3012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: densitas densityai
Densitas, Inc. 510(k) NO: K192973(Special)
ATTN: Mo Abdolell PHONE NO : 1 902 4025505
#66, 1344 Summer Street SE DECISION MADE: 19-FEB-20
Halifax CA B3H0A8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: speX Support Catheter
ReFlow Medical 510(k) NO: K193012(Traditional)
ATTN: Krystal Santiago PHONE NO : 310 7075882
208 Avenida Fabricante #100 SE DECISION MADE: 19-FEB-20
San Clemente CA 92672 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc. 510(k) NO: K193013(Traditional)
ATTN: Karla Schaffner PHONE NO : 1 442 2326161
2210 Faraday Ave., Suite 100 SE DECISION MADE: 11-FEB-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HydroPICC (PICC-142)
Access Vascular, Inc 510(k) NO: K193015(Traditional)
ATTN: Brian Hanley PHONE NO : 781 5386594 101
175 Middlesex Turnpike Suite 1A SE DECISION MADE: 20-FEB-20
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONQUEST FN
Smith & Nephew, Inc. 510(k) NO: K193029(Traditional)
ATTN: Thomas Fearnley PHONE NO : 901 3991224
1450 E Brooks Rd SE DECISION MADE: 28-FEB-20
Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exactech® Equinoxe® Reverse Shoulder Glenospheres
Exactech, Inc 510(k) NO: K193098(Special)
ATTN: Zach Sharrah PHONE NO : 352 3771140
2320 NW 66th Court SE DECISION MADE: 20-FEB-20
Gainesville FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeoBase 2 Non-derivatized MSMS Kit
PerkinElmer Inc. 510(k) NO: K193103(Traditional)
ATTN: Eva Nalian PHONE NO : 1 647 6338435
940 Winter Street SE DECISION MADE: 07-FEB-20
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TGS Guidewire and updated Scopis Software
Stryker ENT 510(k) NO: K193118(Traditional)
ATTN: Bruce Backlund PHONE NO : 763 7625902
3600 Holly Lane North, Suite 40 SE DECISION MADE: 21-FEB-20
Plymouth MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Real Intelligence Cori
Blue Belt Technologies, Inc. 510(k) NO: K193120(Traditional)
ATTN: Corrine Herlinger PHONE NO : 763 4524950
2905 Northwest Blvd. Ste. 40 SE DECISION MADE: 14-FEB-20
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mako Total Hip Application
Mako Surgical Corp. 510(k) NO: K193128(Traditional)
ATTN: Liza Gordillo PHONE NO : 954 6280802
2555 Davie Rd SE DECISION MADE: 02-FEB-20
Fort Lauderdale FL 33317 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Yukon OCT Spinal System
K2M, Inc. 510(k) NO: K193129(Traditional)
ATTN: Oonagh Lahiff PHONE NO :
600 Hope Parkway SE SE DECISION MADE: 07-FEB-20
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Affinity
Hermes Medical Solutions AB 510(k) NO: K193152(Traditional)
ATTN: Joakim Arwidson PHONE NO : 468 190325
Strandbergsgatan 16 SE DECISION MADE: 14-FEB-20
Stockholm SE 11251 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M Attest Super Rapid 5 Steam-Plus Challenge Pack
3M Company 510(k) NO: K193154(Traditional)
ATTN: Mary Fretland PHONE NO : 651 7372296
Bldg. 275-5W-06 SE DECISION MADE: 07-FEB-20
St. Paul MS 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Mini Comprehensive Fixation System - 1.0mm Screws
Arthrex Inc. 510(k) NO: K193156(Traditional)
ATTN: Rebecca R. Homan PHONE NO : 1 239 6435553 73429
1370 Creekside Boulevard SE DECISION MADE: 10-FEB-20
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MectaFix CL Fixation Button with Continuous Loop
Medacta International SA 510(k) NO: K193165(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91696 6060
Strada Regina SE DECISION MADE: 10-FEB-20
Castel San Pietro CH cH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Agilon Moldable
Biogennix, LLC. 510(k) NO: K193168(Traditional)
ATTN: Timothy Bumbalough PHONE NO : 949 2530994
1641 McGaw Ave SE DECISION MADE: 13-FEB-20
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biograph Horizon
Siemens Medical Solution USA, Inc.510(k) NO: K193178(Traditional)
ATTN: Alaine Medio PHONE NO : 865 2060337
810 Innovation Drive SE DECISION MADE: 12-FEB-20
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alliance Augmented Glenoid
Zimmer Inc. 510(k) NO: K193180(Traditional)
ATTN: Patricia Sandborn Beres PHONE NO : 574 2676639
P.O. Box 708 SE DECISION MADE: 24-FEB-20
Warsaw IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOJAVE Expandable Interbody System
K2M, Inc. 510(k) NO: K193203(Special)
ATTN: Oonagh Lahiff PHONE NO :
600 Hope Parkway SE SE DECISION MADE: 18-FEB-20
Leesburg VA 21075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wego-Stainless Steel
Foosin Medical Supplies Inc., Ltd.510(k) NO: K193209(Traditional)
ATTN: Zhipeng Yang PHONE NO : 86 631 5660576
No.20, Xingshan Road, Weihai TorchSE DECISION MADE: 19-FEB-20
Weihai CN 264210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Daytona® Small Stature Growth Rod Conversion Set
SeaSpine Orthopedics Corporation 510(k) NO: K193224(Traditional)
ATTN: Jesse Albright PHONE NO : 760 2165176
5770 Armada Drive SE DECISION MADE: 13-FEB-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology
Covidien LLC 510(k) NO: K193232(Special)
ATTN: Hilla Debby PHONE NO : 972 4 9097774
6135 Gunbarrel Ave SE DECISION MADE: 13-FEB-20
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories
Masimo Corporation 510(k) NO: K193242(Traditional)
ATTN: Sindura Penubarthi PHONE NO : 949 2977592
52 Discovery SE DECISION MADE: 27-FEB-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alta Multipurpose Device
Qfix 510(k) NO: K193243(Traditional)
ATTN: Alexandra Low Smythe PHONE NO : 610 2680585
440 Church Road SE DECISION MADE: 28-FEB-20
Avondale PA 19311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dunamis PunchTac Suture Anchors
Dunamis LLC 510(k) NO: K193245(Special)
ATTN: Prithviraj Chavan PHONE NO : 877 4542186
509 E. Commerce Street Suite 3 SE DECISION MADE: 14-FEB-20
Greenville AL 36037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biograph Vision, Biograph mCT Family of PET/CTs
Siemens Medical Solutions USA, Inc510(k) NO: K193248(Traditional)
ATTN: Tabitha Estes PHONE NO : 865 8044553
810 Innovation Drive SE DECISION MADE: 14-FEB-20
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Largo PEEK Interbody System
FloSpine, LLC 510(k) NO: K193255(Traditional)
ATTN: Peter Harris PHONE NO : 561 7053080
3651 Fau Boulevard, Suite 400 SE DECISION MADE: 20-FEB-20
Boca Raton FL 33431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APrioCore Plus
AprioMed AB 510(k) NO: K193268(Traditional)
ATTN: Katrin Svensson PHONE NO : 46 18 4301440
Virdings Alle 28 SE DECISION MADE: 27-FEB-20
Uppsala SE 75450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rodo Abutment System
RODO Medical, Inc. 510(k) NO: K193274(Traditional)
ATTN: James Park PHONE NO : 1 408 2457636
6399 San Ignacio Ave., Suite 100 SE DECISION MADE: 27-FEB-20
San Jose CA 95119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tinnitus Sound Generator Module
GN Hearing A/S 510(k) NO: K193303(Special)
ATTN: Lars Hagander PHONE NO : 45 45 751111
Lautrupbjerg 7 SE DECISION MADE: 20-FEB-20
Ballerup DK 2750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2 Alpha Tibia Nailing System, IMN Screws System
Stryker Trauma GmbH 510(k) NO: K193308(Traditional)
ATTN: Sanja Jahr PHONE NO : 201 8316797
325 Corporate Drive SE DECISION MADE: 23-FEB-20
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys Anti-TSHR
Roche Diagnostics 510(k) NO: K193313(Traditional)
ATTN: Reanna Toney PHONE NO : 317 5214516
9115 Hague Road SE DECISION MADE: 27-FEB-20
Indianapolis IN 46256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System
Kyocera Medical Technologies, Inc.510(k) NO: K193320(Traditional)
ATTN: Anthony DeBenedictis PHONE NO : 909 5572360
1200 California St, Suite 210 SE DECISION MADE: 04-FEB-20
Redlands CA 92374 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Motion Correction System
KinetiCor, Inc. 510(k) NO: K193324(Traditional)
ATTN: Doug Donzelli PHONE NO : 808 3801444
3465 Waialae Avenue, Suite 300A SE DECISION MADE: 04-FEB-20
Honolulu HI 96816 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERLA® TL posterior osteosynthesis system
Spineart 510(k) NO: K193396(Traditional)
ATTN: Franck Pennesi PHONE NO : 41 22 5701200
3 chemin du pre Fleuri SE DECISION MADE: 05-FEB-20
Plan Les Ouates CH 1228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Summit DuoFix HA Coating
DePuy Orthopaedics, Inc. 510(k) NO: K193398(Special)
ATTN: Erin Combs PHONE NO : 574 3727211
700 Orthopaedic Drive SE DECISION MADE: 04-FEB-20
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXXT MATRIXX System
Nexxt Spine LLC 510(k) NO: K193412(Traditional)
ATTN: Andy Elsbury PHONE NO : 317 4367801
14425 Bergen Blvd, Suite B SE DECISION MADE: 24-FEB-20
Noblesville IN 46060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trigon HA Stand-Alone Wedge Fixation System
Nvision Biomedical Technologies, I510(k) NO: K193414(Traditional)
ATTN: Diana Langham PHONE NO : 210 5453713
4754 Shavano Oak, Suite 101 SE DECISION MADE: 25-FEB-20
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cellvizio I.V.E. with Confocal Miniprobes
Mauna Kea Technologies 510(k) NO: K193416(Traditional)
ATTN: Veronique Dentan PHONE NO : 33 170 080994
9 Rue d'Enghien SE DECISION MADE: 28-FEB-20
Paris FR 75010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Titanium Interference Screws
Biomet Inc. 510(k) NO: K193451(Traditional)
ATTN: Saveetha Raghupathi PHONE NO : 877 6520830 236
56 East Bell Drive, PO Box 587 SE DECISION MADE: 24-FEB-20
Warsaw IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MectaLock All-Suture Anchors
Medacta International SA 510(k) NO: K193461(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 06-FEB-20
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Swan-Ganz Catheters
Edwards Lifesciences, LLC 510(k) NO: K193466(Traditional)
ATTN: Anne Lo PHONE NO : 949 2503386
One Edwards Way SE DECISION MADE: 16-FEB-20
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OrthoCircle Spine Pedicle Screw System
OrthoCircle Spine 510(k) NO: K193472(Traditional)
ATTN: Jack Mathews PHONE NO : 888 4635803
15 East Montgomery Crossroads. SuiSE DECISION MADE: 13-FEB-20
Savannah GA 31406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OneTouch Verio Reflect Blood Glucose Monitoring System
LifeScan Europe GmbH 510(k) NO: K193475(Traditional)
ATTN: Niki Skelly PHONE NO : 44 0 1463383735
Gubelstrasse 34 SE DECISION MADE: 14-FEB-20
Zug CH CH-6300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Basal-IQ Technology
Tandem Diabetes Care, Inc. 510(k) NO: K193483(Traditional)
ATTN: Trevor J Dendo PHONE NO : 858 2246136
11075 Roselle Street SE DECISION MADE: 28-FEB-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA Centaur BR
Siemens Healthcare Diagnostics Inc510(k) NO: K193489(Traditional)
ATTN: Ian Thompson PHONE NO : 914 5242296
511 Benedict Avenue SE DECISION MADE: 13-FEB-20
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infinitt RT PACS
Infinitt Healthcare Co.,Ltd. 510(k) NO: K193498(Traditional)
ATTN: Sang Wook Cho PHONE NO : 82 22192 1631
12F Daerung Post Tower III, 27 DigSE DECISION MADE: 13-FEB-20
Seoul KR 08378 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TGS Universal Headrest with Mounting Arm
Stryker ENT 510(k) NO: K193502(Traditional)
ATTN: Denise Thompson PHONE NO : 269 8880219
3600 Holly Lane North, Suite 40 SE DECISION MADE: 14-FEB-20
Plymouth MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System
NuVasive Incorporated 510(k) NO: K193506(Special)
ATTN: Aditya Sharma PHONE NO : 858 4800263
7475 Lusk Boulevard SE DECISION MADE: 26-FEB-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Steerable Plateau Ti
Life Spine, Inc. 510(k) NO: K193521(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 06-FEB-20
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIN Flexible Nail System
Biomet Inc. 510(k) NO: K193533(Traditional)
ATTN: Dominique Dompor PHONE NO : 877 6520830 169
56 East Bell Drive, PO Box 587 SE DECISION MADE: 20-FEB-20
Warsaw IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Therm-X
Zenith Technical Innovations 510(k) NO: K193550(Traditional)
ATTN: Greg Binversie PHONE NO : 847 6727481
1396 St. Paul Ave. SE DECISION MADE: 28-FEB-20
Gurnee IL 60031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System
Medartis AG 510(k) NO: K193554(Traditional)
ATTN: Andrea Kiefer-Schweizer PHONE NO : 41 61 6333434
Hochbergerstrasse 60E SE DECISION MADE: 16-FEB-20
Basel CH CH-4057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)
BioMerieux, Inc. 510(k) NO: K193567(Traditional)
ATTN: Esther Hernandez PHONE NO : 314 7318841
595 Anglum Road SE DECISION MADE: 14-FEB-20
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sutter Swyng non-stick bipolar forceps, single-use
Sutter Medizintechnik GmbH 510(k) NO: K193587(Traditional)
ATTN: Ulrike Zeissler PHONE NO : 490 761 5155114
Tullastrasse 87 SE DECISION MADE: 10-FEB-20
Freiburg DE 79108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wingman 14, Wingman 14C, Wingman 18, Wingman 35
Reflow Medical 510(k) NO: K193596(Traditional)
ATTN: Krystal Santiago PHONE NO : 310 7075882
208 Avenida Fabricante #100 SE DECISION MADE: 20-FEB-20
San Clemente CA 92672 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BreathID Smart System
Exalenz Bioscience Ltd. 510(k) NO: K193610(Special)
ATTN: Raffi Werner PHONE NO : 011 97289 737502
4 Ha'Maayan st. SE DECISION MADE: 06-FEB-20
Modiin IL 7177872 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-COM DR-2000 DR
LiverMoreTech, Inc. 510(k) NO: K193644(Traditional)
ATTN: Jay Kim PHONE NO : 214 2570113
801 North Jupiter Rd, Suite 200, SE DECISION MADE: 14-FEB-20
Plano TX 75074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uCT 530, uCT 550
Shanghai United Imaging Healthcare510(k) NO: K200016(Traditional)
ATTN: Xin Gao PHONE NO : 86 21 67076888 5386
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 25-FEB-20
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optima Coil System
Balt USA, LLC 510(k) NO: K200030(Special)
ATTN: Michael Peters PHONE NO : 949 7881443
29 Parker SE DECISION MADE: 01-FEB-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endosee System
CooperSurgical, Inc. 510(k) NO: K200038(Special)
ATTN: Christine Kupchick PHONE NO : 203 6015200
95 Corporate Drive SE DECISION MADE: 05-FEB-20
Trumbull CT 06611 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Akesis Galaxy RTx
Akesis Inc 510(k) NO: K200050(Special)
ATTN: Christopher Brown PHONE NO : 1 925 4081381
5129 Commercial Circle SE DECISION MADE: 04-FEB-20
Concord CA 94520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System
Roche Molecular Systems, Inc. 510(k) NO: K200065(Special)
ATTN: Kaitlyn Hameister PHONE NO : 925 7308813
4300 Hacienda Drive SE DECISION MADE: 10-FEB-20
Pleasanton CA 94588-2722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearPoint System and Accessories
MRI Interventions, Inc 510(k) NO: K200079(Special)
ATTN: Pete Piferi PHONE NO : 949 9006833
5 Musick SE DECISION MADE: 13-FEB-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBA Hourglass Peripheral Embolization Device (PED)
Embolic Acceleration, LLC 510(k) NO: K200083(Special)
ATTN: Veronica McDougall PHONE NO : 954 8741016
3451 Commerce Pkwy SE DECISION MADE: 14-FEB-20
Miramar FL 33025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trevo NXT ProVue Retriever
Stryker 510(k) NO: K200117(Special)
ATTN: Germaine Fu PHONE NO : 510 4132862
47900 Bayside Parkway SE DECISION MADE: 07-FEB-20
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M.U.S.T. MINI Posterior Cervical Screws System
Medacta International SA 510(k) NO: K200130(Special)
ATTN: Stefano Baj PHONE NO : 41 91696 6060
Strada Regina SE DECISION MADE: 10-FEB-20
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ashvins
MedicalCommunications GmbH 510(k) NO: K200132(Traditional)
ATTN: Martin Schinkmann PHONE NO : 49 6221 75310
Max-Jarecki-Strasse 8 SE DECISION MADE: 18-FEB-20
Heidelberg DE 69115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LightForce Orthodontic System (LFO System)
LightForce Orthodontics 510(k) NO: K200148(Third Party - Traditional)
ATTN: Amos N Benninga PHONE NO : 800 4810185
1035 Cambridge Street, Suite 14a SE DECISION MADE: 21-FEB-20
Cambridge MA 02141 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 3MP Monochrome Digital Mammography LCD Monitor MS-S300
Jvckenwood Corporation 510(k) NO: K200161(Traditional)
ATTN: Hideki Tengeiji PHONE NO : 81 45450 2715
3-12, Moriya-cho, Kanagawa-ku SE DECISION MADE: 21-FEB-20
Yokohama JP 221-0022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpineNet SSP System
SpineNet LLC 510(k) NO: K200170(Traditional)
ATTN: King Floyd PHONE NO : 407 5392483
1300 Minnesota Ave., Suite 200 SE DECISION MADE: 05-FEB-20
Winter Park FL 32789 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ez3D-i /E3
Ewoosoft Co., Ltd. 510(k) NO: K200178(Special)
ATTN: Young Seok Kim PHONE NO : 82 31 80156172
801-ho, Vatechnetworks Bldg., 13, SE DECISION MADE: 25-FEB-20
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Collaboration Live
Philips Healthcare 510(k) NO: K200179(Third Party - Traditional)
ATTN: Paul Elias PHONE NO : 425 4828396
22100 Bothell Everett Highway SE DECISION MADE: 18-FEB-20
Bothell WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EzRay Air Portable (Model: VEX-P300)
Vatech Co., Ltd 510(k) NO: K200182(Special)
ATTN: Daniel Kim PHONE NO : 82 31 3799492
13, Samsung 1-ro 2-gil SE DECISION MADE: 11-FEB-20
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmoothSkin Pure
CyDen Limited 510(k) NO: K200184(Special)
ATTN: Adam Stephens PHONE NO : 440 1792 274009
Block A, Bay Studios Business ParkSE DECISION MADE: 21-FEB-20
Swansea GB SA1 8QB 510(k) STATEMENT
DEVICE: Luna Dental Implant System- Healing Abutment
Shinhung MST Co., Ltd. 510(k) NO: K200189(Special)
ATTN: Jae Soo Song PHONE NO : 82 33730 1901
110-2, Donghwagong-Ro Munmak-Eup SE DECISION MADE: 26-FEB-20
Wonju Si KR 220-801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARK™ Fentanyl II Assay
ARK Diagnostics, Inc. 510(k) NO: K200197(Traditional)
ATTN: Thomas Houts PHONE NO : 510 2706296
48089 Fremont Boulevard SE DECISION MADE: 26-FEB-20
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter
Stryker Neurovascular 510(k) NO: K200206(Special)
ATTN: Shazia Hakim PHONE NO : 510 4132636
47900 Bayside Parkway SE DECISION MADE: 27-FEB-20
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3D Predict
3D Smile USA, Inc 510(k) NO: K200214(Third Party - Traditional)
ATTN: Marina Domracheva PHONE NO :
3675 Market Street Suite #200 SE DECISION MADE: 24-FEB-20
Philadelphia PA 19104 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor
Mick Radio-Nuclear Instruments, In510(k) NO: K200221(Special)
ATTN: James Hurlman PHONE NO : 914 6673999
521 Homestead Avenue SE DECISION MADE: 28-FEB-20
Mount Vernon NY 10550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arctic Sun Stat Temperature Management System
Medivance, Inc. 510(k) NO: K200225(Special)
ATTN: Jacquelyn Borinski PHONE NO : 720 8805343
321 South Taylor Ave, Suite 200 SE DECISION MADE: 28-FEB-20
Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearCam System
ClearCam, LLC 510(k) NO: K200228(Third Party - Traditional)
ATTN: Chris Idelson PHONE NO : 410 8972858
1601 Trinity St., Bldg B M/S Z-140SE DECISION MADE: 19-FEB-20
Austin TX 78712 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Surgical laser fibers
Quanta System Spa 510(k) NO: K200234(Special)
ATTN: Francesco Dell’Antonio PHONE NO : 39 0331 376797
Via Acquedotto 109 SE DECISION MADE: 25-FEB-20
Samarate (Va) IT 21017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS BRAHMS PCT Reagent Pack and Calibrators
Ortho Clinical Diagnostics 510(k) NO: K200236(Traditional)
ATTN: Ann M Quinn PHONE NO : 585 4534152
100 Indigo Creek Drive SE DECISION MADE: 25-FEB-20
Rochester NY 14626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fusion Quattro Extraction Balloon
Wilson-Cook Medical, Inc 510(k) NO: K200247(Special)
ATTN: Tiffanny A Thomas PHONE NO : 336 7440157 396518
4900 Bethania Station Road SE DECISION MADE: 27-FEB-20
Winston-Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R-Sensor, R-Sensor
Remedi Co. Ltd. 510(k) NO: K200284(Traditional)
ATTN: Jadon Koo PHONE NO : 82 2 69682041
#1409, IS BIZ Tower, 26 YangpyeongSE DECISION MADE: 28-FEB-20
Seoul KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Daytona® Small Stature Spinal System
SeaSpine Orthopedics Corporation 510(k) NO: K200381(Special)
ATTN: Alicia McArthur PHONE NO : 760 2165117
5770 Armada Drive SE DECISION MADE: 28-FEB-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 224
TOTAL WITH SUMMARIES 215
TOTAL WITH STATEMENTS 9
