510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD October 2019
DEVICE: 3d Cage
Fims Co., Ltd. 510(k) NO: K180347(Traditional)
ATTN: Younggwang Choi PHONE NO : 82 70 70986352
Rm 212 Gyeonggi R&DB Center Suwon SE DECISION MADE: 28-OCT-19
Suwon-si KP 16229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acapella Choice Blue Vibratory PEP Device
Smiths Medical 510(k) NO: K181660(Traditional)
ATTN: Donna Semlak PHONE NO : 763 3833076
6000 Nathan Lane North SE DECISION MADE: 24-OCT-19
Minneapolis MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIPOcel
Jeisys Medical, Inc. 510(k) NO: K181896(Traditional)
ATTN: Sugun Lee PHONE NO : 82 2 26036417
307, Daeryung Techno Town 8th, GamSE DECISION MADE: 18-OCT-19
Seoul KR 153-775 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BcSs-PICNI-2000 Sensor
Braincare desenvolvimento e Inovac510(k) NO: K182073(Traditional)
ATTN: Arnaldo Betta PHONE NO : 55 16 35014020
Rua Cid Silva Cesar, 600 sala 6, PSE DECISION MADE: 17-OCT-19
Sao Carlos BR 13562-400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
Shenzhen OSTO Technology Co., Ltd.510(k) NO: K182136(Traditional)
ATTN: Li Yang PHONE NO : 86 755 29769546
No.43 Longfeng Road, Xinsheng CommSE DECISION MADE: 10-OCT-19
Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALFA GATE Dental Implants System
Alfa Gate Mazen Ltd 510(k) NO: K182143(Traditional)
ATTN: Mohamad Zahalka PHONE NO : 972 46356686
Hitin st.2, P.O. Box 301 SE DECISION MADE: 03-OCT-19
Kfar Qara IL 3007500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)
MDK (ShangHai) Medical Packing Co.510(k) NO: K182184(Traditional)
ATTN: Gong Yaoren PHONE NO : 86 18601 673483
No. 233 Fengijan Rd, FengCheng TowSE DECISION MADE: 10-OCT-19
ShangHai CN 201409 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AnyRidge Octa 1 Implant System
MegaGen Implant Co., Ltd. 510(k) NO: K182448(Traditional)
ATTN: HyeJin Jung PHONE NO : 82 53 2222828
45, Secheon-ro, 7-gil, Dasa-eup, DSE DECISION MADE: 09-OCT-19
Daegu KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HS AMICA devices family
HS Hospital Service SPA 510(k) NO: K182605(Traditional)
ATTN: Laura Lenzi PHONE NO : 39 06 9201961
Via A. Vacchi, 23/25 SE DECISION MADE: 28-OCT-19
Aprilia IT 04011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Patient-Specific Airway Stent
New Cos Inc. 510(k) NO: K182743(Traditional)
ATTN: Keith Grafmeyer PHONE NO : 216 8005905 102
7100 Euclid Ave, Ste 180 SE DECISION MADE: 23-OCT-19
Cleveland OH 44103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps
Faulhaber Pinzetten OHG 510(k) NO: K182773(Traditional)
ATTN: Dorothea Faulhaber PHONE NO : 0049 7426 9638530
Daimlerstr. 1 SE DECISION MADE: 08-OCT-19
Frittlingen DE 78665 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Servo Guard
Maquet Critical Care AB 510(k) NO: K182862(Traditional)
ATTN: Elise Brun PHONE NO : 46 10 3357300
Rontgenvagen 2 SE DECISION MADE: 21-OCT-19
Solna SE SE-171 54 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ScopeSeal Duodenoscope Protective Device
GI Scientific LLC 510(k) NO: K183171(Traditional)
ATTN: Scott Miller PHONE NO :
4601 North Fairfax Drive, Suite 12SE DECISION MADE: 08-OCT-19
Arlington VA 22203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Care Orchestrator Essence
Respironics Inc. 510(k) NO: K183226(Traditional)
ATTN: Michelle Brinker PHONE NO : 412 5423538
1001 Murry Ridge Lane SE DECISION MADE: 18-OCT-19
Murrysville PA 15642 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RTHawk, HeartVista Cardiac Package
HeartVista, Inc. 510(k) NO: K183274(Traditional)
ATTN: James J. Rogers PHONE NO : 650 8007937
4984 El Camino Real, Suite 102 SE DECISION MADE: 18-OCT-19
Los Altos CA 94022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: stentfix OTSC System Set
Ovesco Endoscopy AG 510(k) NO: K183309(Traditional)
ATTN: Marc O. Schurr PHONE NO : 49 7071 98979121
Dorfackerstrasse 26 SE DECISION MADE: 22-OCT-19
Tuebingen DE 72074 510(k) STATEMENT
DEVICE: mediCAD Web
mediCAD Hectec GmbH 510(k) NO: K183412(Traditional)
ATTN: Claas-Fabian Lueers PHONE NO : 49 871 33020315
Opalstrasse 54 SE DECISION MADE: 31-OCT-19
Altdorf DE 84032 510(k) STATEMENT
DEVICE: Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs
Semperit Investments Asia PTE LTD.510(k) NO: K183441(Traditional)
ATTN: Andreas Woess PHONE NO : 65 6274 4861
8 Jurong Town Hall Road, #29-03 ToSE DECISION MADE: 04-OCT-19
Singapore SG 609434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Applied Biosystems Bacillus anthracis Detection Kit
MRIGlobal 510(k) NO: K183462(Traditional)
ATTN: Fran White PHONE NO : 816 7537600
425 Volker Boulevard SE DECISION MADE: 01-OCT-19
Kansas City MO 64110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Asthma Monitor AM3
eResearchTechnology 510(k) NO: K183479(Special)
ATTN: Kristin Feld PHONE NO : 0049 9305 72060
Sieboldstrasse 3 SE DECISION MADE: 03-OCT-19
Estenfeld DE 97230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EasyMark Tissue Marker
INRAD Inc. 510(k) NO: K183503(Traditional)
ATTN: Steve Field PHONE NO : 616 3017800
4375 Donker Court SE SE DECISION MADE: 17-OCT-19
Kentwood MI 49512 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs
Encompass Industries Sdn. Bhd. 510(k) NO: K183562(Traditional)
ATTN: Eunice Yee PHONE NO : 60 12 7162339
Lot 18256, Kawasan Perindustrian LSE DECISION MADE: 23-OCT-19
Kemaman MY 24300 510(k) STATEMENT
DEVICE: PMT Facet Screw
Providence Medical Technology, Inc510(k) NO: K183589(Traditional)
ATTN: Edward Liou PHONE NO : 415 9239376
3875 Hopyard Road, Suite 300 SE DECISION MADE: 11-OCT-19
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SomnaPatch
Respironics, Inc. 510(k) NO: K183625(Traditional)
ATTN: Amy Panzik PHONE NO : 412 5423644
1001 Murry Ridge Lane SE DECISION MADE: 18-OCT-19
Murrysville PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearEdge Balance System
Quadrant Biosciences 510(k) NO: K183661(Traditional)
ATTN: Bryan Greene PHONE NO : 716 8034329
505 Irving Avenue SE DECISION MADE: 22-OCT-19
Syracuse NY 13210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electronic Pulse Stimulator
Shenzhen Leading Perfection Techno510(k) NO: K183674(Traditional)
ATTN: Simon Hou PHONE NO : 86 755 29991449
4th Floor, J Building, San Yi Dui SE DECISION MADE: 11-OCT-19
Shenzhen CN 518101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Protego Antimicrobial Wound Dressing
Global Health Solutions (DBA Turn 510(k) NO: K183681(Traditional)
ATTN: Bradley Burnam PHONE NO : 818 3126621
2362 Calabasas Road #100 SE DECISION MADE: 11-OCT-19
Calabasas CA 91302 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivio System
Avicena LLC 510(k) NO: K183710(Traditional)
ATTN: Sean Brady PHONE NO : 626 3449665
2400 Lincoln Ave, Suite 213 SE DECISION MADE: 04-OCT-19
Altadena CA 91001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cronus HP PTA Balloon Catheter
Nipro Medical Corporation 510(k) NO: K190037(Traditional)
ATTN: Jessica Oswald-McLeon PHONE NO : 305 5997174
3150 NW 107th Ave. SE DECISION MADE: 24-OCT-19
Doral FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StimRouter Neuromodulation System
Bioness Inc. 510(k) NO: K190047(Traditional)
ATTN: Sageev George PHONE NO : 661 9025336
25103 Rye Canyon Loop SE DECISION MADE: 31-OCT-19
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Insulin Syringe
Becton Dickinson and Company 510(k) NO: K190054(Traditional)
ATTN: Meriam Youssef PHONE NO : 201 8476557
1 Becton Drive SE DECISION MADE: 21-OCT-19
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Urethrotech UCD
Urethrotech 510(k) NO: K190060(Traditional)
ATTN: Daniela Andrich PHONE NO : 0044 773 0886705
24 Garth Road SE DECISION MADE: 04-OCT-19
Kingston upon Thames GB KT2 5NY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: McLean-Ring Enteral Feeding Tube Set
Cook Incorporated 510(k) NO: K190084(Traditional)
ATTN: Paul Meyer PHONE NO : 812 3353575 105299
750 Daniels Way SE DECISION MADE: 11-OCT-19
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cepheid Xpert Respiratory Control Panel
Microbiologics, Inc. 510(k) NO: K190086(Traditional)
ATTN: Tina Sobania PHONE NO : 320 2297050
200 Cooper Avenue North SE DECISION MADE: 07-OCT-19
St. Cloud MN 56303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System
Osprey Medical Inc. 510(k) NO: K190102(Traditional)
ATTN: Melanie Hess PHONE NO : 952 9558252
5600 Rowland Road Suite 250 SE DECISION MADE: 17-OCT-19
Minnetonka MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One
E.M.S Electro Medical Systems S.A.510(k) NO: K190124(Traditional)
ATTN: Gaelle Pacaud PHONE NO : 41 22 9944700
Chemin de la Vuarpilliere 31 SE DECISION MADE: 20-OCT-19
Nyon CH CH-1260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fusion Silastic System
Fusion Orthopedics, LLC 510(k) NO: K190136(Traditional)
ATTN: Eli Jacobson PHONE NO : 800 4036876
4135 S. Power Rd., Suite 110 SE DECISION MADE: 21-OCT-19
Mesa AZ 85212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vial Adapter Ø20 mm
Avenir Performance Europeenne Medi510(k) NO: K190149(Traditional)
ATTN: Fatoumata Dao PHONE NO : 00 33 164785100
ZI Route de Souppes SE DECISION MADE: 15-OCT-19
Château-Landon FR 77570 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diana ChemoClave Transfer Set
ICU Medical 510(k) NO: K190157(Traditional)
ATTN: Jason Ma PHONE NO : 224 7062411
600 Field Drive SE DECISION MADE: 23-OCT-19
Lake Forest IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmartCeph
Ortho2, LLC 510(k) NO: K190162(Traditional)
ATTN: Amy Schmidt PHONE NO : 515 2331026
1107 Buckeye Avenue SE DECISION MADE: 17-OCT-19
Ames IA 50010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAHARA Stabilization System
K2M, Inc. 510(k) NO: K190179(Traditional)
ATTN: Oonagh Lahiff PHONE NO :
600 Hope Parkway SE SE DECISION MADE: 03-OCT-19
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Instruments for LINK MEGASYSTEM-C Family
Link Bio Corp. 510(k) NO: K190181(Traditional)
ATTN: Terry Powell PHONE NO : 973 6251333
101 Roundhill Drive SE DECISION MADE: 25-OCT-19
Rockaway NJ 07866 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe
Anhui Hongyu Wuzhou Medical Manufa510(k) NO: K190183(Traditional)
ATTN: Gang Yu PHONE NO : 86 0556 5129666
No. 2 Guanyin Road Economic DeveloSE DECISION MADE: 04-OCT-19
Taihu, Anqing City CN 246400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
Diversatek Healthcare 510(k) NO: K190208(Traditional)
ATTN: Laura L. Boll PHONE NO : 303 4707020 4806
9150 Commerce Center Circle Suite SE DECISION MADE: 03-OCT-19
Highlands Ranch CO 80129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tear Pool Dissolvable Punctum Plugs
AlphaMed Inc 510(k) NO: K190210(Traditional)
ATTN: James Gubachy PHONE NO : 915 5952020
3912 Mountain Ave SE DECISION MADE: 24-OCT-19
El Paso TX 79930 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IOB Warming Blankets
IOB Medical Inc 510(k) NO: K190221(Traditional)
ATTN: Jiulin Xia PHONE NO : 301 2500831
504E Diamond Ave., Suite I SE DECISION MADE: 25-OCT-19
Gaithersburg MD 20877 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZE SIT Valvulotome
LeMaitre Vascular 510(k) NO: K190267(Traditional)
ATTN: John N. Bradsher PHONE NO : 781 4251685
63 Second Avenue SE DECISION MADE: 30-OCT-19
Burlington MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORE-SIGHT ELITE Tissue Oximeter Module
CAS Medical Systems, Inc. 510(k) NO: K190270(Traditional)
ATTN: Ron Jeffrey PHONE NO : 203 4886056
44 East Industrial Road SE DECISION MADE: 21-OCT-19
Branford CT 06405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultrasonic Surgical System
MediSonic Technology Co 510(k) NO: K190281(Abbreviated)
ATTN: Reginald Bart-Williams PHONE NO : 770 3776365
11411 Southern Highlands Parkway, SE DECISION MADE: 31-OCT-19
Las Vegas NV 89141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
Beckman Coulter Biomedical GmbH 510(k) NO: K190298(Traditional)
ATTN: Amanda Brown PHONE NO : 49 173 5698563
Sauerbruchstr. 50 SE DECISION MADE: 04-OCT-19
Munich DE 81377 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000
MedNovel Technology Ltd 510(k) NO: K190314(Traditional)
ATTN: Jia Yu PHONE NO : 510 2261689
1154 Cadillac Court SE DECISION MADE: 09-OCT-19
Milpitas CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Waterlase Laser System Family
Biolase, Inc. 510(k) NO: K190319(Traditional)
ATTN: Alicia Mszyca PHONE NO : 949 2268471
4 Cromwell SE DECISION MADE: 10-OCT-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pediatric Nailing Platform|Femur
OrthoPediatrics, Corp. 510(k) NO: K190321(Special)
ATTN: Jen Gregory PHONE NO : 574 2680880
2850 Frontier Drive SE DECISION MADE: 09-OCT-19
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIAFINE Topical Cream
Bausch Health Americas Incorporate510(k) NO: K190342(Traditional)
ATTN: Marci Halevi PHONE NO : 908 9525174
1400 N. Goodman St. 14609 USA SE DECISION MADE: 18-OCT-19
Rochester NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MediExpand TL Expandable VBR System
CMF Medicon Surgical Inc. 510(k) NO: K190349(Traditional)
ATTN: Therese Davey PHONE NO : 904 6427500
11200 St. Johns Industrial Pkwy N,SE DECISION MADE: 24-OCT-19
Jacksonville FL 32246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KTA Adipose Treatment Kit
Stemics S.A.S 510(k) NO: K190386(Traditional)
ATTN: Stephane Giraud PHONE NO : 33 967 501298
2 Rue Professeur Paul Milleret SE DECISION MADE: 10-OCT-19
Besancon FR 25000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALTA Anterior Cervical Corpectomy System
Astura Medical, LLC 510(k) NO: K190426(Traditional)
ATTN: Parker Kelch PHONE NO : 760 8148047
3186 Lionshead Ave, Suite 100 SE DECISION MADE: 24-OCT-19
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Evolve Breast Pump
Hygeia II Medical Group, Inc. 510(k) NO: K190465(Special)
ATTN: Brett Nakfoor PHONE NO : 714 5157571
6241 Yarrow Drive SE DECISION MADE: 18-OCT-19
Carlsbad CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pitkar External Fixation System
S H Pitkar Orthotools Pvt Ltd. 510(k) NO: K190486(Traditional)
ATTN: Vivek Mangalwedhekar PHONE NO : 912 04 0706464
Plot No. EL 32, J Block, MIDC BhosSE DECISION MADE: 16-OCT-19
Pune IN 411026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial
OssDsign AB 510(k) NO: K190523(Traditional)
ATTN: Ulrik Birgersson PHONE NO : 46 0 18553993
Virdings Alle 2 SE DECISION MADE: 10-OCT-19
Uppsala SE SE 754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIO-I
WaisMed Ltd 510(k) NO: K190538(Traditional)
ATTN: Maya Shuvi PHONE NO : 972 72 2234585
10 Amal St Afeck Industrial Park SE DECISION MADE: 07-OCT-19
Rosh Haayin IL 4809234 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile
MonuMedical, LLC 510(k) NO: K190539(Traditional)
ATTN: John Knapik PHONE NO : 855 6668633
3017 Douglas Blvd, Suite 300 SE DECISION MADE: 22-OCT-19
Roseville CA 95661 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zimmer Biomet Universal Navigation System
Zimmer Biomet Spine, Inc. 510(k) NO: K190556(Traditional)
ATTN: Kelly Stratton PHONE NO : 303 5018386
10225 Westmoor Drive SE DECISION MADE: 24-OCT-19
Westminster CO 80021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safergel Sterile Ultrasound Gel
Safersonic US, Inc. 510(k) NO: K190591(Traditional)
ATTN: David L. Seitelman PHONE NO : 847 2741534
2873 Arlington AV, Ste. 110 SE DECISION MADE: 04-OCT-19
Highland Park IL 60035 510(k) STATEMENT
DEVICE: EarlyVue VS30
Philips Medizin Systeme Boeblingen510(k) NO: K190624(Traditional)
ATTN: Greg Li PHONE NO : 978 6594227
Hewlett-Packard Strasse 2 SE DECISION MADE: 27-OCT-19
Boeblingen DE 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SolidAIRity III Airway Stabilization System
Securisyn Medical, LLC 510(k) NO: K190630(Traditional)
ATTN: Arthur Kanowitz PHONE NO : 720 6413540
9150 Commerce Center Circle, SuiteSE DECISION MADE: 09-OCT-19
Highlands Ranch CO 80129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein
Lenora Glove PVT LTD. 510(k) NO: K190632(Abbreviated)
ATTN: Antony Kurian PHONE NO : 91422 2656 4432656941
Plot No: 15/104-1, Rottigoundanur,SE DECISION MADE: 24-OCT-19
Coimbatore IN 641105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive® Reline® 4.5-5.0 System
NuVasive, Incorporated 510(k) NO: K190636(Traditional)
ATTN: Ivanna Lopez PHONE NO : 858 9091878
7475 Lusk Boulevard SE DECISION MADE: 19-OCT-19
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QT Scanner 2000 Model A
QT Ultrasound, LLC 510(k) NO: K190646(Traditional)
ATTN: Rajni Natesan PHONE NO : 415 8427244
3 Hamilton Landing, Suite 160 SE DECISION MADE: 18-OCT-19
Novato CA 94949 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)
Fisher & Paykel Healthcare Ltd. 510(k) NO: K190713(Traditional)
ATTN: Masar Mohammad PHONE NO : 64 9 5740100
15 Maurice Paykel Place, East TamaSE DECISION MADE: 11-OCT-19
Auckland NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Claritag
DGI Technologies 510(k) NO: K190747(Traditional)
ATTN: Jeremy Josephson PHONE NO : 732 8875087
500 River Ave SE DECISION MADE: 31-OCT-19
Lakewood NJ 08701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K190772(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 10-OCT-19
Hachioji-Shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tetragraph Neuromuscular Transmission Monitor
Senzime AB 510(k) NO: K190795(Traditional)
ATTN: Johanna Faris PHONE NO : 46 705 286330
Ulls vag 29B SE DECISION MADE: 18-OCT-19
Uppsala SE 756 51 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aimanfun Lumea Comfort
Kam Yuen Plastic Products Ltd 510(k) NO: K190820(Traditional)
ATTN: Anna Dan PHONE NO : 86 0760 88413080
No. 2, Heng Feng Two Road, Pu Jin SE DECISION MADE: 02-OCT-19
Zhongshan CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medtronic Transportation / Sterilization Cassettes
Medtronic Sofamor Danek USA, INC. 510(k) NO: K190840(Traditional)
ATTN: Elizabeth Hamilton PHONE NO : 901 3963133
1800 Pyramid Place SE DECISION MADE: 15-OCT-19
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REDAPT Blade Augments
Smith & Nephew, Inc. 510(k) NO: K190847(Traditional)
ATTN: Konrad Wolfmeyer PHONE NO : 901 3991367
1450 Brooks Road SE DECISION MADE: 25-OCT-19
Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exactech Alteon Modular Dual Mobility (MDM) System
Exactech, Inc. 510(k) NO: K190890(Traditional)
ATTN: Liz Howell PHONE NO : 352 3771140
2320 NW 66th Court SE DECISION MADE: 22-OCT-19
Gainesville FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Low Profile Screws
Arthrex Inc. 510(k) NO: K190921(Traditional)
ATTN: Heli F. Chambi Infantas PHONE NO : 239 6435553 71263
1370 Creekside Boulevard SE DECISION MADE: 30-OCT-19
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Echelon Endopath Staple Line Reinforcement
Ethicon Endo-Surgery LLC 510(k) NO: K190937(Traditional)
ATTN: Emily Nesbitt PHONE NO : 787 2726144
475 Calle C SE DECISION MADE: 14-OCT-19
Guaynabo PR 00696 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tokuyama Rebase III
Tokuyama Dental Corporation 510(k) NO: K190940(Traditional)
ATTN: Keith A. Barritt PHONE NO : 202 7835070
38-9 Taitou 1-chome, Taitou-ku SE DECISION MADE: 04-OCT-19
Tokyo JP 110-0016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Minimally Invasive Ankle Fusion Plate
Arthrex, Inc. 510(k) NO: K190953(Traditional)
ATTN: Caroline Bloemker PHONE NO : 239 6435553 71639
1370 Creekside Boulevard SE DECISION MADE: 16-OCT-19
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OR3O Dual Mobility System
Smith & Nephew, Inc. 510(k) NO: K191002(Traditional)
ATTN: Mike Scott PHONE NO : 901 3991633
7135 Goodlett Farms Parkway SE DECISION MADE: 31-OCT-19
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems
Supersonic Imagine 510(k) NO: K191007(Traditional)
ATTN: Jacques Souquet PHONE NO : 33 44 2992424
Les Jardins de la Duranne - Bat E&SE DECISION MADE: 25-OCT-19
Aix-en-Provence FR 13857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Palladium High Flow Therapy System
Vapotherm, Inc. 510(k) NO: K191010(Third Party - Traditional)
ATTN: Richelle Helman PHONE NO : 603 6580489
100 Domain Drive SE DECISION MADE: 10-OCT-19
Exeter NH 03833 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CD Horizon™ Astute™ Spinal System
Medtronic Sofamor Danek, USA Inc. 510(k) NO: K191066(Traditional)
ATTN: Bhavya Vendra PHONE NO : 901 3993248
1800 Pyramid Place SE DECISION MADE: 03-OCT-19
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter
Vein360, LLC 510(k) NO: K191073(Traditional)
ATTN: Suzanne Meyer PHONE NO : 513 5541300
4460 Lake Forest Drive SE DECISION MADE: 22-OCT-19
Blue Ash OH 45242-3741 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Maverick RNP Assay and Maverick Diagnostic System
Genalyte, Inc. 510(k) NO: K191085(Traditional)
ATTN: Rick Hockett PHONE NO : 858 9561200 305
10520 Wateridge Circle SE DECISION MADE: 25-OCT-19
San Diego CA 92121 510(k) STATEMENT
DEVICE: Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
Atlas Medical 510(k) NO: K191099(Traditional)
ATTN: Amani AL-Habahbeh PHONE NO : 96 2 64026468
King Abdullah Industrial Estate, SSE DECISION MADE: 03-OCT-19
Amman JO 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advanced Intermezzo Implant System
MegaGen Implant Co., Ltd. 510(k) NO: K191127(Traditional)
ATTN: JiYoung Son PHONE NO : 82 53 2222988
45, Secheon-ro, 7-gil, Dasa-eup, DSE DECISION MADE: 08-OCT-19
Daegu KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KATANA Cleaner, KATANA Cleaner (Trial)
Kuraray Noritake Dental Inc. 510(k) NO: K191133(Traditional)
ATTN: Yasujiro Ohara PHONE NO : 81 3 67011736
Ote Center Bldg. 7F SE DECISION MADE: 08-OCT-19
Chiyoda-ku JP 100-0004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IB3D ALIF
Medicrea International S.A. 510(k) NO: K191134(Traditional)
ATTN: David Ryan PHONE NO : 00 334 72018787
5389, route de Strasbourg SE DECISION MADE: 30-OCT-19
Rillieux-la-Pape FR 69140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bodycad Unicompartmental Knee System
Bodycad Laboratories, Inc. 510(k) NO: K191150(Traditional)
ATTN: Guy Sevigny PHONE NO : 418 5271388
2035, rue du Haut-Bord SE DECISION MADE: 08-OCT-19
Quebec City CA g1n 4r7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter
Innovative Health, LLC. 510(k) NO: K191170(Traditional)
ATTN: Amanda Babcock PHONE NO : 480 5255911
1435 North Hayden Road, Suite 100 SE DECISION MADE: 30-OCT-19
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mercy babyTAPE
Children's Mercy Hospital 510(k) NO: K191174(Traditional)
ATTN: Susan Abdel-Rahman PHONE NO : 816 3023003
2401 Gilham Road SE DECISION MADE: 10-OCT-19
Kansas City MO 64108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NXPRO Neuromuscular Electrical Stimulation Device
NeuX Technologies, Inc. 510(k) NO: K191181(Traditional)
ATTN: Scot Minniear PHONE NO : 561 5101882
3802 Spectrum Blvd. Suite 112F SE DECISION MADE: 11-OCT-19
Tampa FL 33612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spectra Cashmere
Uzinmedicare Co. 510(k) NO: K191208(Special)
ATTN: Nathan Ahn PHONE NO : 82 31 3751076
56, Dongtansandan 5-Gil, Dongtan-MSE DECISION MADE: 11-OCT-19
Hwaseong-Si KR 18487 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voxel Dosimetry™ v1.0
Hermes Medical Solutions AB 510(k) NO: K191216(Traditional)
ATTN: Joakim Arwidson PHONE NO : 46 81 90325
Strandbergsgatan 16 SE DECISION MADE: 17-OCT-19
Stockholm SE 11251 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infared Thermometer
Shenzhen Calibeur Industries Co., 510(k) NO: K191251(Traditional)
ATTN: Weibin He PHONE NO : 86 755 26010950
No. 11 Bldg., Shiguan industrial PSE DECISION MADE: 15-OCT-19
Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intraosseous infusion device
Einstein Works, L.L.C. 510(k) NO: K191258(Traditional)
ATTN: Linda Taylor PHONE NO : 888 7377978
5312 Elm Street SE DECISION MADE: 23-OCT-19
Houston TX 77081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)
Ujenzi Charitable Trust 510(k) NO: K191264(Traditional)
ATTN: Thomas Burke PHONE NO : 617 5840064
22 Welgate Road SE DECISION MADE: 30-OCT-19
Medford MA 02155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer, Breeze model
Suzhou Melodicare Medical Technolo510(k) NO: K191283(Traditional)
ATTN: Xiaoqian Zou PHONE NO : 86 791 85216384
Building Room 301, No 32 Hongxi RoSE DECISION MADE: 18-OCT-19
Suzhou CN 215163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module
Arthrex Inc. 510(k) NO: K191326(Traditional)
ATTN: Rebecca R. Homan PHONE NO : 1 239 5984302 73429
1370 Creekside Boulevard SE DECISION MADE: 15-OCT-19
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XACT Robotic System
XACT Robotics Ltd. 510(k) NO: K191332(Traditional)
ATTN: Chen Levin PHONE NO : 972 4 7700153
8 Hatochen Street, PO Box 3097 SE DECISION MADE: 03-OCT-19
Caesarea IL 3079861 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module
Arthrex Inc. 510(k) NO: K191344(Traditional)
ATTN: Rebecca R. Homan R. Homan PHONE NO : 1 239 5984302 73429
1370 Creekside Boulevard SE DECISION MADE: 03-OCT-19
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trident II Acetabular System
Howmedica Osteonics Corp. aka Stry510(k) NO: K191358(Special)
ATTN: Valerie Giambanco PHONE NO : 201 8316275
325 Corporate Drive SE DECISION MADE: 24-OCT-19
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nipro Syringe
Nipro Medical Corporation 510(k) NO: K191359(Traditional)
ATTN: Jessica Oswald-McLeod PHONE NO : 786 5676343
3150 NW 107th Ave. SE DECISION MADE: 09-OCT-19
Doral FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neocis Planning Software Application (NPSA) for 3rd Party PCs
Neocis Inc. 510(k) NO: K191363(Traditional)
ATTN: Thomas ("Ted") E. Claiborne PHONE NO : 631 7938945
2800 Biscayne Blvd Suite 600 SE DECISION MADE: 02-OCT-19
Miami FL 33137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSolution One Total Knee Application
THINK Surgical, Inc. 510(k) NO: K191369(Traditional)
ATTN: Meliha Mulalic PHONE NO : 510 2492337
47201 Lakeview Blvd SE DECISION MADE: 08-OCT-19
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VICRYL Mesh
Ethicon, Inc. 510(k) NO: K191373(Traditional)
ATTN: Melina Escobar PHONE NO : 908 2182583
Route 22 West, P.O. Box 151 SE DECISION MADE: 22-OCT-19
Somerville NJ 08876-0151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRILLIANT COMPONEER
Coltene/Whaledent AG 510(k) NO: K191385(Traditional)
ATTN: Wolfgang Dorner PHONE NO : 0041 75 7575422
Feldwiesenstrasse 20 SE DECISION MADE: 29-OCT-19
Altstatten CH 9450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OxySoft (olifilcon C) silicone hydrogel soft contact lens
Visco Vision Inc. 510(k) NO: K191397(Traditional)
ATTN: Evan Huang PHONE NO : 886 3 3596868
No. 1, Xingye St. Guishan Dist. SE DECISION MADE: 02-OCT-19
Taoyuan TW 33341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Belun Ring
Belun Technology Company Limited 510(k) NO: K191417(Traditional)
ATTN: Leung Lap Wai Lydia PHONE NO : 852 3706 5640
Rm531B, floor 5, Core Building 2, SE DECISION MADE: 10-OCT-19
Sha Tin HK 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reusable SpO2 Sensor
Shenzhen Changke Connect Electroni510(k) NO: K191420(Traditional)
ATTN: Yahui Zhou PHONE NO : 86 136 13012560
A2-4th floor of Xiang dali TechnolSE DECISION MADE: 11-OCT-19
Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter
Shenzhen Yimi Life-Technology Co.,510(k) NO: K191430(Traditional)
ATTN: Shande Peng PHONE NO : 86 755 86573112
305 Tengbo Industrial Park, ChangsSE DECISION MADE: 18-OCT-19
Shenzhen CN 518118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Interlude Rolled Tampons in Plastic Applicator
ALBAAD fem 510(k) NO: K191431(Traditional)
ATTN: Shlomo Helvits PHONE NO : 972 4 6223860
1, Alon Hatavor St. SE DECISION MADE: 07-OCT-19
Caesarea Ind. Park IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Saalio
Saalmann medical GmbH & Co. KG 510(k) NO: K191436(Traditional)
ATTN: Rolf Eilers PHONE NO : 49 0 5731254500
Sudbahnstrabe 34 SE DECISION MADE: 18-OCT-19
Bad Oeynhausen DE 32547 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Barrier Sleeves
Ivoclar Vivadent, AG 510(k) NO: K191448(Traditional)
ATTN: Sandra Cakebread PHONE NO : 423 235 3535
Bendererstrasse 2 SE DECISION MADE: 08-OCT-19
Schaan LI FL-9494 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Legacy SMARTBase Abutments
Implant Direct Sybron Manufacturin510(k) NO: K191458(Traditional)
ATTN: Reina Choi PHONE NO : 818 4443306
3050 East Hillcrest Drive SE DECISION MADE: 10-OCT-19
Thousand Oaks CA 91362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-CAT Anaesthesia Catheter kit
Cimpax ApS 510(k) NO: K191470(Traditional)
ATTN: Patrick Busch-Madsen PHONE NO : 45 55 380381
Lille Pilevang 4 SE DECISION MADE: 25-OCT-19
Slangerup DK 3550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)
Trigg Laboratories, Inc. D/B/A Wet510(k) NO: K191480(Traditional)
ATTN: Louie Goryoka PHONE NO : 702 9574400 101
4220 W Windmill Lane, Suite 140 SE DECISION MADE: 11-OCT-19
Las Vegas CA 89139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe
Jiangsu Caina Medical Co., Ltd. 510(k) NO: K191490(Traditional)
ATTN: Xinyan Ruan PHONE NO : 86 510 86205183
No.23, Huanxi Road, Zhutang Town SE DECISION MADE: 03-OCT-19
Jiangyin CN 214425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ventripoint Medical System Plus (VMS+) 3.0
Ventripoint Diagnostics, Ltd. 510(k) NO: K191493(Traditional)
ATTN: Desmond Hirson PHONE NO : 416 8480709
2 Sheppard Avenue East, Suite 605 SE DECISION MADE: 16-OCT-19
Toronto CA M2N 5Y7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intellijoint® Navigation System
Intellijoint Surgical Inc. 510(k) NO: K191507(Traditional)
ATTN: Breanne Cuddington PHONE NO : 519 3423178
60 Bathurst Drive Unit 6 SE DECISION MADE: 01-OCT-19
Waterloo CA N2V 2A9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Altapore Shape
Baxter Healthcare Corporation 510(k) NO: K191513(Traditional)
ATTN: Phillip Romei PHONE NO : 224 9482652
32650 N. Wilson Road SE DECISION MADE: 19-OCT-19
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Visalys Restorative Primer
Kettenbach GmbH & Co. KG 510(k) NO: K191523(Traditional)
ATTN: Katja Simon PHONE NO : 49 2774 7050
Im Heerfeld 7 SE DECISION MADE: 09-OCT-19
Eschenburg DE 35713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cardioblate CryoFlex Surgical Ablation System
Medtronic, Inc. 510(k) NO: K191526(Special)
ATTN: Choua Thao PHONE NO : 763 5149842
3800 Annapolis Lane SE DECISION MADE: 01-OCT-19
Plymouth MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apyx Plasma/RF Handpiece
Bovie Medical Corporation dba Apyx510(k) NO: K191542(Traditional)
ATTN: Topaz Kirlew PHONE NO : 727 8038617
5115 Ulmerton Road SE DECISION MADE: 11-OCT-19
Clearwater FL 33760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synapse 3D Blood Flow Analysis
Fujifilm Corporation 510(k) NO: K191544(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
26-30 Nishiazabu, 2-Chome SE DECISION MADE: 18-OCT-19
Minato-Ku Tokyo JP 106-8620 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nexus Universal Self-Cure
Kerr Corporation 510(k) NO: K191548(Traditional)
ATTN: Ardrena Jackson PHONE NO : 714 5167334
1717 W. Collins Ave SE DECISION MADE: 11-OCT-19
Orange CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FILTRAY 2G Disposable Water Filters
aqua-tools 510(k) NO: K191563(Traditional)
ATTN: Virginie S. Grondin PHONE NO : 33 1 39750220
26, rue Charles Edouard Jeanneret SE DECISION MADE: 25-OCT-19
Poissy FR 78300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORTICO Anterior Cervical Fixation System
Camber Spine Technologies LLC 510(k) NO: K191584(Traditional)
ATTN: Rami Hamzey PHONE NO : 484 4277060
501 Allendale Road SE DECISION MADE: 22-OCT-19
King of Prussia PA 19406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arcadia Balloon Catheter
Merit Medical Systems, Inc. 510(k) NO: K191596(Traditional)
ATTN: Shamsa Karimi PHONE NO : 408 7701115
1600 West Merit Parkway SE DECISION MADE: 09-OCT-19
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RTapp
SegAna, LLC 510(k) NO: K191610(Traditional)
ATTN: Rodney Bosley PHONE NO : 610 2134379
3259 Progress Drive SE DECISION MADE: 01-OCT-19
Orlando FL 32826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROFEMUR TL2 Stems
MicroPort Orthopedics Inc. 510(k) NO: K191632(Traditional)
ATTN: Sneh Pingle PHONE NO : 901 8674656
5677 Airline Road SE DECISION MADE: 07-OCT-19
Memphis TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Freestyle Flex
Medela AG 510(k) NO: K191653(Traditional)
ATTN: Judith Bernardo PHONE NO : 41 41 5621656
Laettichstrasse 4b SE DECISION MADE: 17-OCT-19
Baar Zug CH CH-6341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Instylla Delivery Kit
Instylla, Inc. 510(k) NO: K191659(Traditional)
ATTN: Amita Smith PHONE NO : 781 7904857 1003
204 Second Avenue SE DECISION MADE: 10-OCT-19
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Forehead Thermometer (Model IR-FT)
Comper Chuangxiang (Beijing) Techn510(k) NO: K191668(Traditional)
ATTN: Han Du PHONE NO : 086 10 57480968
Room 102-103 1st Floor, Building 4SE DECISION MADE: 18-OCT-19
Daxing District CN 100176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuFACE Mini Device
Carol Cole Company dba NuFACE 510(k) NO: K191672(Traditional)
ATTN: Nadia Vazirzadeh Miller PHONE NO : 760 5091259
1325 Sycamore Avenue, Suite A SE DECISION MADE: 15-OCT-19
Vista CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
Integra Lifesciences Corporation 510(k) NO: K191684(Traditional)
ATTN: Omayra Ramirez PHONE NO : 787 2293434
311 Enterprise Drive SE DECISION MADE: 11-OCT-19
Plainsboro NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
phenox Limited 510(k) NO: K191687(Third Party - Traditional)
ATTN: Gary Brogan PHONE NO : 353 91 740103
Kamrick Court, Ballybrit Business SE DECISION MADE: 09-OCT-19
Galway IE H91XY38 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)
Omega Medical Imaging, LLC 510(k) NO: K191713(Traditional)
ATTN: John Newman PHONE NO : 407 3239400
3400 St. Johns Parkway, Suite 1020SE DECISION MADE: 04-OCT-19
Sanford FL 32771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATEC IOM Accessory Instruments
Alphatec Spine, Inc. 510(k) NO: K191723(Traditional)
ATTN: Ruby Zheng PHONE NO : 760 4946884
5818 El Camino Real SE DECISION MADE: 18-OCT-19
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ePM Series Patient monitors
Shenzhen Mindray Bio-medical Elect510(k) NO: K191769(Traditional)
ATTN: Yanhong Bai PHONE NO : 86 755 81888998
Mindray Building, Keji 12th Road SSE DECISION MADE: 31-OCT-19
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECURE Screw
A.M. Surgical, Inc. 510(k) NO: K191771(Traditional)
ATTN: Vincent Pascale PHONE NO : 1 631 9799777
285 Middle Country Road, Suite 206SE DECISION MADE: 16-OCT-19
Smithtown NY 11787 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Attune Revision LPS Inserts
Depuy (Ireland) 510(k) NO: K191779(Traditional)
ATTN: Kathy Harris PHONE NO : 1 574 3727020
Loughbeg Ringaskiddy SE DECISION MADE: 08-OCT-19
Co. Cork Munster IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Parcus Synd-EZ Ti
Parcus Medical, LLC 510(k) NO: K191783(Special)
ATTN: Paul Vagts PHONE NO : 941 7557965
6423 Parkland Dr SE DECISION MADE: 09-OCT-19
Sarasota FL 34243 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vintage Art Universal
Shofu Dental Corporation 510(k) NO: K191794(Traditional)
ATTN: Mauro Malzyner PHONE NO : 760 7363277 202
1225 Stone Drive SE DECISION MADE: 03-OCT-19
San Marcos CA 92078 510(k) STATEMENT
DEVICE: Propex IQ Apex Locator
Dentsply Sirona 510(k) NO: K191806(Traditional)
ATTN: Karl Nittinger PHONE NO : 717 8494424
221 West Philadelphia Street SuiteSE DECISION MADE: 03-OCT-19
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device
ALPCO 510(k) NO: K191807(Traditional)
ATTN: Jeffrey Freedman PHONE NO : 603 8938914
26 Keewaydin Drive, Unit G SE DECISION MADE: 25-OCT-19
Salem NH 03079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADI Cervical Interbody Fusion Device
Additive Device, Inc. (ADI) d/b/a 510(k) NO: K191812(Traditional)
ATTN: Nathan Evans PHONE NO : 984 8880593
311 W Corporation St SE DECISION MADE: 24-OCT-19
Durham NC 27701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alliance Glenoid
Zimmer Inc. 510(k) NO: K191814(Traditional)
ATTN: Patricia Sandborn Beres PHONE NO : 574 2676639
P.O. Box 708 SE DECISION MADE: 23-OCT-19
Warsaw IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nano FortiCore, FortiCore
Nanovis LLC 510(k) NO: K191822(Traditional)
ATTN: Matthew Hedrick PHONE NO : 877 9076266
5865 East State Rd. 14 SE DECISION MADE: 11-OCT-19
Columbia City IN 46725 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dexcom G6 Pro Continuous Glucose Monitoring System
Dexcom, Inc. 510(k) NO: K191833(Traditional)
ATTN: Jacob Nardone PHONE NO : 858 2036337
6310 Sequence Dr. SE DECISION MADE: 07-OCT-19
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ceramill A-Temp
Amann Girrbach AG 510(k) NO: K191843(Traditional)
ATTN: Debora Engel PHONE NO : 49 7231 957260
Herrschaftswiesen 1 SE DECISION MADE: 04-OCT-19
Koblach AT 6842 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Premia Spine XL Instruments
Premia Spine, Ltd. 510(k) NO: K191854(Traditional)
ATTN: Ron Sacher PHONE NO : 972 72 2281200
7 Giborey Israel Street SE DECISION MADE: 08-OCT-19
Ramat Poleg IL 42504 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EmFace Device
InMode MD Ltd. 510(k) NO: K191855(Traditional)
ATTN: Amit Goren PHONE NO : 972 4 9097470
Tabor Building, Shaar Yokneam SE DECISION MADE: 29-OCT-19
Yoqneam Illit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Compression Therapy Device Model LGT-2200SP
Guangzhou Longest Science & Techno510(k) NO: K191862(Traditional)
ATTN: Xiaobing Luo PHONE NO : 86 020 66353999
5&6f, Building B4, No.11, Kaiyuan SE DECISION MADE: 29-OCT-19
Guangzhou CN 510530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F5 Corpus VS
Permobil AB 510(k) NO: K191874(Traditional)
ATTN: Ivan Fernandez PHONE NO : 800 7360925
Box 120 S-861 23 SE DECISION MADE: 25-OCT-19
Timra SE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun
KBL GmbH 510(k) NO: K191881(Special)
ATTN: Ralf de Andreis PHONE NO : 490 2689 9426850
Ringstrasse 24-26 SE DECISION MADE: 28-OCT-19
Dernbach DE 56307 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NG-Test CARBA 5
NG Biotech 510(k) NO: K191889(Traditional)
ATTN: Milovan Stankov-Puges PHONE NO : 33 02 23301783
Z.A. Courbouton, secteur 1, AtelieSE DECISION MADE: 02-OCT-19
Guipry FR 35480 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Belimed Steam Sterilizer MST-H TOP 5000
Belimed AG 510(k) NO: K191896(Abbreviated)
ATTN: Marc Luthi PHONE NO : 41 71 6448780
Grienbachstrasse 11 SE DECISION MADE: 31-OCT-19
Zug CH 6300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Razor, Everest, U&C Liquid
U&C International Co., Ltd. 510(k) NO: K191902(Traditional)
ATTN: Jong-min Kim PHONE NO : 82 02 8657714
RM 1F/2F, 13, Digital-ro 27-gil, GSE DECISION MADE: 11-OCT-19
Seoul KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MATRx Plus
Zephyr Sleep Technologies 510(k) NO: K191925(Traditional)
ATTN: Sabina Bruehlmann PHONE NO : 587 3171976
102, 701 64 Ave SE SE DECISION MADE: 29-OCT-19
Calgary CA T2H-2C3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Momentum™ Posterior Spinal Fixation System
Ulrich Medical USA 510(k) NO: K191932(Traditional)
ATTN: Hans Stover PHONE NO : 636 5190268
5865 East State Rd.14 SE DECISION MADE: 02-OCT-19
Chesterfield MO 63005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MT One Diamond
M&T Srl 510(k) NO: K191942(Traditional)
ATTN: Firorenzo Rossi PHONE NO : 39 054 1727486
Via Pietrarubbia, 32/F SE DECISION MADE: 17-OCT-19
Rimini IT 4700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set
Medos International, SARL 510(k) NO: K191943(Traditional)
ATTN: Daria Bochenek PHONE NO : 41 61 9656154
Chemin-Blanc 38 SE DECISION MADE: 18-OCT-19
Le Loche CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MU2net
DOSIsoft 510(k) NO: K191944(Traditional)
ATTN: Marc Usynski PHONE NO : 33 141 242626
45/47, Avenue Carnot SE DECISION MADE: 24-OCT-19
Cachan FR 94230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD MAX Vaginal Panel
GeneOhm Sciences Canada, Inc. (BD 510(k) NO: K191957(Traditional)
ATTN: Katie Edwards PHONE NO : 410 3164975
2555 Boul. du Parc-Technologique SE DECISION MADE: 21-OCT-19
Quebec CA GIP 4S5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aveta System
Meditrina, Inc. 510(k) NO: K191958(Special)
ATTN: Csaba Truckai PHONE NO : 408 4714877
1190 Saratoga Avenue, Suite 180 SE DECISION MADE: 01-OCT-19
San Jose CA 95129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMR Finned Short Stems
LimaCorporate S.p.A 510(k) NO: K191963(Traditional)
ATTN: Giuseppe Valenti PHONE NO : 39 04 32945511
Via Nazionale 52 SE DECISION MADE: 10-OCT-19
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lumpipulse G CA19-9-N
Fujirebio Dianostics, Inc. 510(k) NO: K191973(Traditional)
ATTN: Kristin Maddaloni PHONE NO : 484 3952126
201 Great Valley Parkway SE DECISION MADE: 22-OCT-19
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORO QR3 XTom Headholder System
Pro Med Instruments GmbH 510(k) NO: K191979(Traditional)
ATTN: Sandra Untenberger PHONE NO : 49 76 138422210
Boetzinger Str. 38 SE DECISION MADE: 22-OCT-19
Freiburg DE 79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Yumizen C1200 CRP
Horiba ABX SAS 510(k) NO: K191993(Traditional)
ATTN: Caroline Ferrer PHONE NO : 0033 4670 141516
Parc Euromedecine, Rue du Caducee SE DECISION MADE: 03-OCT-19
Montpellier Cedex 4 FR 341184 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProFound AI Software V2.1
iCAD Inc. 510(k) NO: K191994(Traditional)
ATTN: Heather Reed PHONE NO : 603 3091945
98 Spit Brook Rd. Suite 100 SE DECISION MADE: 04-OCT-19
Nashua NH 03062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterilucent VH2O2 Chemical Indicators
Sterilucent, Inc. 510(k) NO: K191999(Traditional)
ATTN: Peter Kalkbrenner PHONE NO : 612 7673253
1400 Marshall St. NE SE DECISION MADE: 21-OCT-19
Minneapolis MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device
Sterilucent, Inc. 510(k) NO: K192001(Traditional)
ATTN: Peter Kalkbrenner PHONE NO : 612 7673253
1400 Marshall St. NE SE DECISION MADE: 22-OCT-19
Minneapolis MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bausch + Lomb PreVue Inserter for enVista Preloaded
Bausch & Lomb, Inc 510(k) NO: K192005(Special)
ATTN: Rekha Janarthanan PHONE NO : 636 2263095
3365 Tree ct. Industrial Blvd. SE DECISION MADE: 04-OCT-19
St. Louis MO 63122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann PUREloc abutments
Institut Straumann AG 510(k) NO: K192029(Traditional)
ATTN: Giulia Oran PHONE NO : 41 619 651617
Peter Merian Weg 12 SE DECISION MADE: 28-OCT-19
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G21 SpaceFlex Hip
G21 S.r.l 510(k) NO: K192041(Traditional)
ATTN: Filippo Foroni PHONE NO : 39 053 530312
Via Sandro Petrini, 8 SE DECISION MADE: 29-OCT-19
San Possidonio IT 41039 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
DiaSorin Inc. 510(k) NO: K192046(Traditional)
ATTN: John C. Walter PHONE NO : 651 4399710
1951 Northwestern Ave. SE DECISION MADE: 28-OCT-19
Stillwater MN 55082-0285 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: W Zirconia Implants
TAV Medical Ltd. 510(k) NO: K192053(Traditional)
ATTN: Revital Shabtai PHONE NO : 972 4 9808615
Dora Industrial Park, P.O. Box 88 SE DECISION MADE: 29-OCT-19
Shlomi IL 2283202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall
Terumo Europe N.V. 510(k) NO: K192057(Special)
ATTN: M. J. Aerts PHONE NO : 32 16 381211
Interleuvenlaan 40 SE DECISION MADE: 11-OCT-19
Leuven BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON Vitamin B12
DiaSorin Inc. 510(k) NO: K192064(Traditional)
ATTN: John C. Walter PHONE NO : 651 4399710
1951 Northwestern Ave SE DECISION MADE: 02-OCT-19
Stillwater MN 55082-0285 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Okami Medical LOBO Vascular Occlusion System
Okami Medical 510(k) NO: K192083(Traditional)
ATTN: Rebecca K Pine PHONE NO : 760 8095178
8 Argonaut, Suite 100 SE DECISION MADE: 30-OCT-19
Aliso Viejo CA 92656 510(k) STATEMENT
DEVICE: Madison Total Knee System
Implanet, S.A. 510(k) NO: K192084(Traditional)
ATTN: Regis Le Couedic PHONE NO : 33 557 995555
Technopole Bordeaux Montesquieu, ASE DECISION MADE: 22-OCT-19
Martillac FR 33650 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vitek Densichek
bioMerieux, Inc 510(k) NO: K192110(Traditional)
ATTN: Jennifer Jines PHONE NO : 314 7318352
595 Anglum Rd. SE DECISION MADE: 31-OCT-19
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Game Ready GRPro 2.1 System
Cool Systems, Inc. (dba Game Ready510(k) NO: K192114(Traditional)
ATTN: Natalie Kennel PHONE NO : 510 9845351
1800 Sutter Street, Suite 500 SE DECISION MADE: 29-OCT-19
Concord CA 94520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Black Diamond Pedicle Screw System
Osseus Fusion Systems 510(k) NO: K192121(Traditional)
ATTN: Robert Pace PHONE NO : 214 3950100
2703 Mockingbird Lane, Suite 102 SE DECISION MADE: 29-OCT-19
Dallas TX 75235 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sutter Arrowtip Monopolar Electrodes
Sutter Medizintechnik GmbH 510(k) NO: K192128(Traditional)
ATTN: Ulrike Zeissler PHONE NO : 49 0761 515514
Tullastrasse 87 SE DECISION MADE: 04-OCT-19
Freiburg DE 79108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zimmer Biomet Universal Navigation System
Zimmer Biomet Spine, Inc. 510(k) NO: K192133(Traditional)
ATTN: Alex Pawlowski PHONE NO : 303 5331062
10225 Westmoor Dr. SE DECISION MADE: 29-OCT-19
Westminster CO 80021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Halyard ONE-STEP* Sterilization Wrap
Owens & Minor (O&M) Halyard, Inc 510(k) NO: K192147(Traditional)
ATTN: Steven Dowdley PHONE NO :
9120 Lockwood Blvd SE DECISION MADE: 10-OCT-19
Mechanicsville VA 23116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROSA ONE Spine application
MEDTECH S.A. 510(k) NO: K192173(Traditional)
ATTN: Serge Tabet PHONE NO : 33 467 107740
ZAC Eureka - 900 Rue du Mas de VerSE DECISION MADE: 29-OCT-19
Montpellier FR 34000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: On Call Express II Blood Glucose Monitoring System
ACON Laboratories, Inc. 510(k) NO: K192175(Special)
ATTN: Qiyi Xie PHONE NO : 858 8758011
10125 Mesa Rim Road SE DECISION MADE: 17-OCT-19
San Diego CA 92121 510(k) STATEMENT
DEVICE: The Cellfina System
Ulthera, Inc 510(k) NO: K192185(Traditional)
ATTN: Lisa Pray PHONE NO : 480 6454979
1840 S. Stapley Dr. Suite 200 SE DECISION MADE: 09-OCT-19
Mesa AZ 85204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TotalShield II Surgical Helmet System
Zimmer Surgical, Inc 510(k) NO: K192194(Special)
ATTN: Abigail Miller PHONE NO : 330 3438801
200 West Ohio Avenue SE DECISION MADE: 15-OCT-19
Dover OH 44622 510(k) STATEMENT
DEVICE: DynaCAD
Invivo Corporation 510(k) NO: K192200(Third Party - Traditional)
ATTN: Kym Rupp PHONE NO : 425 4877127
3545 SW 47th Ave. SE DECISION MADE: 09-OCT-19
Gainesville FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 32mm Glenosphere and Humeral Cup
FX Shoulder USA, Inc. 510(k) NO: K192206(Traditional)
ATTN: Kathy Trier PHONE NO : 800 2800775
13465 Midway Road, Suite 101 SE DECISION MADE: 08-OCT-19
Dallas TX 75244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORNICE Cervical Spacer System
Legend Spine Technologies 510(k) NO: K192208(Traditional)
ATTN: Steve Marinelli PHONE NO : 267 5663273
1803 Apple Tree Lane SE DECISION MADE: 09-OCT-19
Bethlehem PA 18015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
Fiab SpA 510(k) NO: K192210(Traditional)
ATTN: Francesco Batistini PHONE NO : 003 9055 8497974
Via Costoli, 4 SE DECISION MADE: 10-OCT-19
Vicchio IT 50039 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CarboClear VBR System
CarboFix Orthopedics Ltd. 510(k) NO: K192214(Traditional)
ATTN: Yael Rubin PHONE NO : 972 9 9511511
11 Ha'hoshlim St. SE DECISION MADE: 11-OCT-19
Herzeliya IL 4672411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEON Laparoscopic Instruments
Lexington Medical, Inc. 510(k) NO: K192235(Traditional)
ATTN: Douglas MacBride PHONE NO : 617 2099817
11 Executive Park Drive SE DECISION MADE: 11-OCT-19
Billerica MA 01862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WavelinQ Plus EndoAVF System
C.R. Bard, Inc. 510(k) NO: K192239(Traditional)
ATTN: Kulveen Dhatt PHONE NO : 480 3792875
1625 West 3rd Street SE DECISION MADE: 17-OCT-19
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL
Thermo Fisher Scientific 510(k) NO: K192250(Traditional)
ATTN: Cynthia Knapp PHONE NO : 800 8718909322 4117
1 Thermo Fisher Way SE DECISION MADE: 16-OCT-19
Oakwood Village OH 440146 510(k) STATEMENT
DEVICE: Europa Pedicle Screw System
MiRus, LLC 510(k) NO: K192268(Traditional)
ATTN: Jordan Bauman PHONE NO : 678 3246272
1755 West Oak Parkway, Suite 100 SE DECISION MADE: 22-OCT-19
Marietta GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Medical ED-3490TK Video Duodenoscope
Pentax Medical 510(k) NO: K192280(Traditional)
ATTN: William Goeller PHONE NO : 201 5712318
3 Paragon Drive SE DECISION MADE: 21-OCT-19
Montvale NJ 07645 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ExactVu High Resolution Micro-Ultrasound System
Exact Imaging Inc. 510(k) NO: K192303(Third Party - Traditional)
ATTN: Sam Rajkumar PHONE NO : 1 905 4151654
7676 Woodbine Avenue Unit 15 SE DECISION MADE: 01-OCT-19
Markham CA L3R 2N2 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Zimmer Natural Nail System Cephalomedullary Nails
Zimmer GmbH 510(k) NO: K192312(Special)
ATTN: Annemie Rehor Kausch PHONE NO : 41 58 8548261
Sulzerallee 8 SE DECISION MADE: 11-OCT-19
Winterthur CH 8404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESONATE Anterior Cervical Plate System
Globus Medical Inc. 510(k) NO: K192314(Traditional)
ATTN: Kelly J Baker PHONE NO : 610 9301800 1670
2560 General Armistead Ave. SE DECISION MADE: 23-OCT-19
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Matrix HA PEEK Cervical Implant System
Sapphire Medical Group 510(k) NO: K192316(Special)
ATTN: Anthony Ruggiero PHONE NO : 949 9398502
32565 B Golden Lantern Street, SuiSE DECISION MADE: 17-OCT-19
Dana Point CA 92629 510(k) STATEMENT
DEVICE: Ultraverse 014 and 018 PTA Balloon Dilatation Catheters
Bard Peripheral Vascular, Inc. 510(k) NO: K192318(Third Party - Traditional)
ATTN: Andrew Quach PHONE NO : 480 4492587
1625 West 3rd St SE DECISION MADE: 03-OCT-19
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Quantum Blood and Fluid Warming System
Life Warmer, Inc. 510(k) NO: K192325(Special)
ATTN: John Pettini PHONE NO : 469 3941155
4813 Keller Springs Rd SE DECISION MADE: 18-OCT-19
Addison TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
Liofilchem s. r. l. 510(k) NO: K192345(Traditional)
ATTN: Fabio Brocco PHONE NO : 39 085 8930745
Via Scozia zona ind.le SE DECISION MADE: 31-OCT-19
Roseto degli Abruzzi IT 64026 510(k) STATEMENT
DEVICE: IntellaMap Orion High Resolution Mapping Catheter
Boston Scienfitic Corporation 510(k) NO: K192360(Traditional)
ATTN: Nicole Lyden PHONE NO : 651 5826344
4100 Hamline Ave North SE DECISION MADE: 25-OCT-19
St.Paul MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
iXensor Co. Ltd. 510(k) NO: K192369(Traditional)
ATTN: Evita Chen PHONE NO : 886 2 87511335
6F., No.9, Aly. 2, Ln. 35, Jihu RoSE DECISION MADE: 29-OCT-19
Taipei City TW 114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Millenium HX
Mar Cor Purification, Inc. 510(k) NO: K192398(Special)
ATTN: Mike Halliday PHONE NO : 800 6333080 2106
14550 28th Avenue North SE DECISION MADE: 03-OCT-19
Minneapolis MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG
DRTECH Corporation 510(k) NO: K192400(Special)
ATTN: Choul-Woo Shin PHONE NO : 82 31 7797783
Suite No.1, 1 Floor / Suite No.2, SE DECISION MADE: 03-OCT-19
Jungwon-gu, Seongam-si KR 13216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System
Zimmer GmbH 510(k) NO: K192416(Special)
ATTN: Roberto Tommasini PHONE NO : 41 5885 48619
Sulzerallee 8 SE DECISION MADE: 01-OCT-19
Winterthur CH 8404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Steerable Introducer 12F
Freudenberg Medical LLC 510(k) NO: K192422(Third Party - Traditional)
ATTN: Mary Prunty PHONE NO : 812 2802354
2301 Centennial Boulevard SE DECISION MADE: 04-OCT-19
Jeffersonville IN 47130 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Mobius3D
Varian Medical Systems, Inc 510(k) NO: K192424(Special)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
3100 Hansen Way SE DECISION MADE: 03-OCT-19
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Signa Voyager, Signa Voyager Quantum
GE Healthcare(Tianjin) Company Lim510(k) NO: K192426(Special)
ATTN: Yuan Ma PHONE NO : 86 181011 31106
No. 266 Jinjsan Road, Tianjin AirpSE DECISION MADE: 01-OCT-19
Tianjin CN 300308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ablation Confirmation
NeuWave Medical, Inc. 510(k) NO: K192427(Special)
ATTN: Neda Chini PHONE NO : 949 7898656
3529 Anderson Street SE DECISION MADE: 03-OCT-19
Madison WI 53704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFX Femoral Implant with Inserter
Cayenne Medical 510(k) NO: K192428(Special)
ATTN: Shima Hashemian PHONE NO : 480 4582196
16597 N 92nd Street SE DECISION MADE: 05-OCT-19
Scottsdale AZ 85260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LZI Methadone II Enzyme Immunoassay
Lin-Zhi International, Inc 510(k) NO: K192433(Traditional)
ATTN: Bernice Lin PHONE NO : 408 9708811
2945 Oakmead Village Court SE DECISION MADE: 04-OCT-19
Santa Clara CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DualX Lumbar Intervertebral Body Fusion Device
Amplify Surgical Inc 510(k) NO: K192434(Special)
ATTN: Andy Choi PHONE NO : 765 2675439
27071 Cabot Road, Suite 118 SE DECISION MADE: 15-OCT-19
Laguna Hills CA 82653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex SwiveLock Anchors
Arthrex Inc. 510(k) NO: K192441(Special)
ATTN: Jessica L. Singelais PHONE NO : 1 239 5984302 73091
1370 Creekside Boulevard SE DECISION MADE: 17-OCT-19
Naples FL 34108-5553 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Delta Xtend Revers Shoulder System
DePuy(Ireland) 510(k) NO: K192448(Special)
ATTN: Ashley Goncalo PHONE NO :
Loughbeg Ringaskiddy SE DECISION MADE: 04-OCT-19
Co.Cork Munster IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMOND-5A/6A/8A
DRGEM Corporation 510(k) NO: K192453(Special)
ATTN: Ki-Nam Yang PHONE NO :
7F E-B/D Gwangmyeong Techno-Park 6SE DECISION MADE: 01-OCT-19
Gwangmyeong-si KR 14322 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Merge PACS
Merge Healthcare Incorporated 510(k) NO: K192455(Traditional)
ATTN: Amy Tannenbaum PHONE NO : 262 3670700
900 Walnut Ridge Drive SE DECISION MADE: 17-OCT-19
Hartland WI 53209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DigiFix Sterile Kit
Virak Orthopedics, LLC 510(k) NO: K192465(Special)
ATTN: Virak Tan PHONE NO : 1 908 2171413
620 Essex St SE DECISION MADE: 10-OCT-19
Harrison NJ 07029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERA
Reflexion Health, Inc. 510(k) NO: K192474(Special)
ATTN: Walter Cordiglia PHONE NO : 619 6377018
225 Broadway Ste. 300 SE DECISION MADE: 10-OCT-19
San Diego CA 62101 510(k) STATEMENT
DEVICE: NexGen Anterior Cervical Plate System
Precision Spine 510(k) NO: K192494(Traditional)
ATTN: Michael C. Dawson PHONE NO : 973 4557150 128
2050 Executive Drive SE DECISION MADE: 29-OCT-19
Pearl MS 39208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Treace Medical Concepts (TMC) Plating System
Treace Medical Concepts, Inc. 510(k) NO: K192504(Special)
ATTN: Rachel Osbeck PHONE NO : 904 3735940
203 Fort Wade Rd., Suite 150 SE DECISION MADE: 30-OCT-19
Ponte Vedra FL 32081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Focus 35C Detector, Trimax 35C Detector
iRay Technology Taicang Ltd. 510(k) NO: K192512(Special)
ATTN: Meng Li PHONE NO : 0086 0512 53690872
No.33 Xinggang Rd., Taicang Port ESE DECISION MADE: 16-OCT-19
Taicang CN 215434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20
Shenzhen Bioeasy Biotechnology Co.510(k) NO: K192515(Traditional)
ATTN: Wenhau Yan PHONE NO : 86 755279 48546
No.2-1, Liuxian 1st Road, Xin'an SSE DECISION MADE: 11-OCT-19
Shenzhen CN 518101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reusable Monopolar Active Cord
US Endoscopy 510(k) NO: K192518(Traditional)
ATTN: Gregory Land PHONE NO : 440 3927424
5976 Heisley Road SE DECISION MADE: 25-OCT-19
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 087 Balloon Guide Catheter System
Q'Apel Medical LLC 510(k) NO: K192525(Traditional)
ATTN: Ken Peartree PHONE NO : 310 3953950
330 Wilshire Boulevard SE DECISION MADE: 31-OCT-19
Santa Monica CA 90401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spine Wave Navigated Instruments
Spine Wave, Inc. 510(k) NO: K192526(Special)
ATTN: Amy Noccioli PHONE NO : 203 9449494
3 Enterprise Drive, Suite 210 SE DECISION MADE: 10-OCT-19
Shelton CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex SwiveLock Anchor
Arthrex Inc. 510(k) NO: K192532(Special)
ATTN: Ivette Galmez PHONE NO : 1 239 6435553 71263
1370 Creekside Boulevard SE DECISION MADE: 19-OCT-19
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DigiX FDX
Allengers Medical Systems Limited 510(k) NO: K192541(Special)
ATTN: Sanjeev K. Marjara PHONE NO : 91 1762 272600
Bhankharpur, Mubarakpur Road SE DECISION MADE: 16-OCT-19
Derabassi, Distt Mohali IN 140507510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Carnation Ambulatory Monitor
Bardy Diagnostics, Inc 510(k) NO: K192556(Special)
ATTN: Jocelyn Kersten PHONE NO : 425 7615912
316 Occidental Avenue South, SuiteSE DECISION MADE: 17-OCT-19
Seattle WA 98104 510(k) STATEMENT
DEVICE: Reach and CQ'ENCE Circular Staplers
Reach Surgical, Inc. 510(k) NO: K192566(Special)
ATTN: Mark Goldin PHONE NO : 86 22 25326259
120 Xinxing Road West Zone, TEDA SE DECISION MADE: 17-OCT-19
Tianjin CN 300462 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Confirm Rx Insertable Cardiac Monitor
Abbott 510(k) NO: K192593(Special)
ATTN: Laura Sparks PHONE NO : 818 34932734
15900 Valley View Ct. SE DECISION MADE: 18-OCT-19
Sylmar CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bashir S-B Endovascular Catheter
Thrombolex, Inc. 510(k) NO: K192598(Special)
ATTN: Amy Katsikis PHONE NO : 267 8983986
75 New Britain Dr. SE DECISION MADE: 18-OCT-19
New Britain PA 18901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)
Aziyo Biologics, Inc. 510(k) NO: K192616(Special)
ATTN: Wendy Perreault PHONE NO :
1100 Old Ellis Road, Suite 1200 SE DECISION MADE: 21-OCT-19
Roswell GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LipiFlow Thermal Pulsation System
TearScience Inc. 510(k) NO: K192623(Special)
ATTN: Michelle Ricafort PHONE NO : 714 2478434
1700 East St. Andrew Place SE DECISION MADE: 22-OCT-19
Santa Ana CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omnipod Insulin Management System, Omnipod DASH Insulin Management System
Insulet Corporation 510(k) NO: K192659(Traditional)
ATTN: Julie Perkins PHONE NO : 978 6007951
100 Nagog Park SE DECISION MADE: 21-OCT-19
Acton MA 01720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: gel-e Flex+ gel OTC
gel-e, Inc. 510(k) NO: K192667(Special)
ATTN: Elsa Abruzzo PHONE NO : 301 4053585
387 Technology Dr., Suite 3110B SE DECISION MADE: 25-OCT-19
College Park MD 20742 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228
3M Company 510(k) NO: K192673(Special)
ATTN: Mary Fretland PHONE NO : 651 7372296
3M Center, Building 275-5W-06 SE DECISION MADE: 28-OCT-19
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Genesys Spine Binary® Lumbar Plate System
Genesys Spine 510(k) NO: K192678(Special)
ATTN: Chloe Lance PHONE NO : 512 3817070
1250 Capital of Texas Highway SoutSE DECISION MADE: 24-OCT-19
Austin TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Revolution Maxima, Revolution Ace
GE Hangwei Medical Systems Co.,Ltd510(k) NO: K192686(Special)
ATTN: Haibo He PHONE NO : 86 10 57083413
West Area of Building No.3, No.1 YSE DECISION MADE: 24-OCT-19
Beijing Economic and Technological510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Upgrade Kit MR GUI PRO, MrJ 3300 Plus
ASG Superconductors S.p.A. 510(k) NO: K192690(Special)
ATTN: De Benedetti Luisella PHONE NO : 39 010 6489358
Corso Ferdinando Maria Perrone 73/SE DECISION MADE: 24-OCT-19
Genova IT 16152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MiniCap Extended Life PD Transfer Sets
Baxter Healthcare 510(k) NO: K192705(Special)
ATTN: Kimberly Garcia PHONE NO : 224 2704401
32650 N. Wilson Road SE DECISION MADE: 25-OCT-19
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Padlock Clip defect closure system, Padlock Pro-Select defect closure device
STERIS Corporation 510(k) NO: K192722(Special)
ATTN: Tony Piotrkowski PHONE NO : 440 3927437
5796 Heisley Road SE DECISION MADE: 24-OCT-19
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cytal Wound Matrix 3-Layer
ACell, Inc. 510(k) NO: K192725(Special)
ATTN: Michelle Huettner PHONE NO : 410 7171700
6640 Eli Whitney Drive Suite 200 SE DECISION MADE: 25-OCT-19
Columbia MD 21046 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Agnes
Agnes Medical Co., Ltd 510(k) NO: K192728(Special)
ATTN: SeungHwan Seo PHONE NO : 82 31 80209702
(Seohyeon-Dong, 5f Cocoplaza), 20,SE DECISION MADE: 24-OCT-19
Seongnam-Si KR 13591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RCT800
RAY CO., Ltd 510(k) NO: K192737(Traditional)
ATTN: Changhwan Lee PHONE NO : 82 35 6051000
332-7, Samsung 1-ro SE DECISION MADE: 22-OCT-19
Hwaseong-si KR 18380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VisionX 2.4
Durr Dental SE 510(k) NO: K192743(Traditional)
ATTN: Oliver Lange PHONE NO : 49 071427 050
Hopfigheimer Str. 17 SE DECISION MADE: 31-OCT-19
Bietigheim-Bissingen DE 74321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive Modulus XLIF Interbody System
NuVasive, Incorporated 510(k) NO: K192760(Traditional)
ATTN: Jessica LeBlanc PHONE NO : 858 9093302
7475 Lusk Blvd. SE DECISION MADE: 18-OCT-19
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri
Stereotaxis, Inc. 510(k) NO: K192775(Special)
ATTN: Kenneth H. Lock PHONE NO : 314 6786123
4320 Forest Park Avenue, Suite 100SE DECISION MADE: 30-OCT-19
St. Louis MO 63108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile
Scientia Vascular LLC 510(k) NO: K192783(Special)
ATTN: Amy McManus PHONE NO : 888 3859016
3487 West 2100 South Suite 100 SE DECISION MADE: 30-OCT-19
West Valley City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System
Dexcom, Inc. 510(k) NO: K192787(Special)
ATTN: Bryan Osborne PHONE NO : 858 8759896
6310 Sequence Dr. SE DECISION MADE: 25-OCT-19
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atellica IM Total hCG (ThCG)
Siemens Healthcare Diagnostics Inc510(k) NO: K192790(Traditional)
ATTN: Mey Lyn Vasquez PHONE NO : 914 5242458
511 Benedict Ave. SE DECISION MADE: 30-OCT-19
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: primeMidline Catheters
PFM Medical, Inc. 510(k) NO: K192802(Special)
ATTN: Mina Jiang PHONE NO : 760 7588749
1916 Palomar Oaks Way, Suite 150 SE DECISION MADE: 28-OCT-19
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System
Siemens Medical Solutions, USA, In510(k) NO: K192835(Third Party - Traditional)
ATTN: Hyunjung Lee PHONE NO : 425 2815061
22010 South East 51st Street SE DECISION MADE: 22-OCT-19
Issaquah WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)
Bovie Medical Corporation dba Apyx510(k) NO: K192867(Third Party - Traditional)
ATTN: Topaz Kirlew PHONE NO : 727 8038617
5115 Ulmerton Road SE DECISION MADE: 31-OCT-19
Clearwater FL 33760-4004 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ADH19
3M Deutschland GmbH 510(k) NO: K192961(Third Party - Traditional)
ATTN: Ruediger Franke PHONE NO : 49 8152 7001802
ESPE Platz SE DECISION MADE: 31-OCT-19
Seefeld DE 82229 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 266
TOTAL WITH SUMMARIES 252
TOTAL WITH STATEMENTS 14
