FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Gastroenterology & Urology ×
9,870 results
1777–1800 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Mar 21, 2016
Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip...
K160229 · FCG
Cook Ireland, Ltd.
Gastroenterology & Urology · 49d
Cleared Mar 18, 2016
DBB-06 Hemodialysis Delivery System
K152938 · KDI
NIKKISO CO., LTD.
Gastroenterology & Urology · 165d
Cleared Mar 17, 2016
Rezum System
K160417 · KNS
Nxthera, Inc.
Gastroenterology & Urology · 30d
Cleared Mar 15, 2016
NeoTract UroLift System UL500
K153584 · PEW
Neotract, Inc.
Gastroenterology & Urology · 91d
Cleared Mar 03, 2016
Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
K153206 · FDS
Fujifilm Medical System U.S.A., Inc.
Gastroenterology & Urology · 119d
Cleared Mar 03, 2016
FULL CARE Disposable PVC Nelaton Catheter
K151745 · EZD
Shaoxing Fuqing Health Products Co.,...
Gastroenterology & Urology · 248d
Cleared Mar 02, 2016
Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
K160241 · KNS
Olympus Medical Systems Corp.
Gastroenterology & Urology · 30d
Cleared Mar 01, 2016
xevonta dialyzer
K143482 · KDI
B. Braun Avitum AG
Gastroenterology & Urology · 449d
Cleared Feb 25, 2016
Mammotome revolve Dual Vacuum Assist Biopsy System
K152989 · KNW
Devicor Medical Products, Inc.
Gastroenterology & Urology · 135d
Cleared Feb 24, 2016
EndoChoice Water Bottle Cap System
K153588 · FEQ
Endochoice, Inc.
Gastroenterology & Urology · 70d
Cleared Feb 24, 2016
Oxyless Blood Tubing Set
K150304 · FJK
Oxyless, Ltd.
Gastroenterology & Urology · 383d
Cleared Feb 23, 2016
UreTron MultiProbe Lithotripter System
K160198 · FFK
Med-Sonics Corp.
Gastroenterology & Urology · 26d
Cleared Feb 23, 2016
Fujifilm Video Colonoscope Model EC-600WL V2
K160196 · FDF
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 27d
Cleared Feb 19, 2016
Low Potassium Dextran Solution with Tris Diluent
K153384 · KDN
United Therapeutics Corporation
Gastroenterology & Urology · 88d
Cleared Feb 18, 2016
Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)
K151474 · KGE
Fujifilm Medical System U.S.A., Inc.
Gastroenterology & Urology · 262d
Cleared Feb 15, 2016
Intact® Gen2 System
K152596 · KNW
Intact Medical Corporation
Gastroenterology & Urology · 158d
Cleared Feb 12, 2016
Single Use Injector NM600/610
K153625 · FBK
Olympus Medical Systems Corp.
Gastroenterology & Urology · 56d
Cleared Feb 12, 2016
X-Suit NIR Biliary Metallic Stent
K150487 · FGE
Medinol, Ltd.
Gastroenterology & Urology · 352d
Cleared Feb 09, 2016
ENDOFLOW II - Irrigation, Warming and Suction System
K152278 · OCX
Promepla Sam
Gastroenterology & Urology · 181d
Cleared Feb 09, 2016
Actreen Mini Intermittent Urinary Catheters
K151772 · GBM
B.Braun Medical, Inc.
Gastroenterology & Urology · 224d
Cleared Feb 09, 2016
CapsoCam (SV-1)
K151635 · NEZ
CapsoVision, Inc.
Gastroenterology & Urology · 237d
Cleared Feb 09, 2016
Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
K151308 · FGA
Schoelly Fiberoptic GmbH
Gastroenterology & Urology · 267d
Cleared Feb 09, 2016
Nutrisafe 2- ENFit Adaptor
K151237 · PIO
Vygon
Gastroenterology & Urology · 274d
Cleared Feb 08, 2016
EndoChoice Select Injection Needle
K151475 · FBK
Endochoice, Inc.
Gastroenterology & Urology · 251d