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
1585–1608 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Aug 11, 2017
Diacap Pro Dialyzer
K170574 · KDI
B. Braun Avitum AG
Gastroenterology & Urology · 165d
Cleared Aug 09, 2017
Epic Biliary Endoscopic Stent System
K171809 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 51d
Cleared Aug 08, 2017
Delta III Lithotripter
K172084 · LNS
Dornier Medtech America, Inc.
Gastroenterology & Urology · 29d
Cleared Aug 04, 2017
ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle
K171596 · FCG
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 65d
Cleared Aug 03, 2017
Medrobotics Flex Robotic System
K172036 · FDF
Medrobotics Corporation
Gastroenterology & Urology · 29d
Cleared Aug 01, 2017
14Fr Colon Decompression Set, Macon Colon Decompression Set
K171619 · FEG
Cook Ireland, Ltd.
Gastroenterology & Urology · 60d
Cleared Jul 31, 2017
Nasal Pancreatic Drainage Set
K171623 · FGE
Cook Ireland, Ltd.
Gastroenterology & Urology · 59d
Cleared Jul 31, 2017
Bronchi and Gastrointestinal Cytology Brush
K171607 · FDX
Wilson-Cook Medical Inc./Cook Endoscopy
Gastroenterology & Urology · 60d
Cleared Jul 28, 2017
Williams Cystoscopic Injection Needle
K171602 · FBK
Cook Incorporated
Gastroenterology & Urology · 57d
Cleared Jul 25, 2017
FTRD System Set
K170867 · PKL
Ovesco Endoscopy AG
Gastroenterology & Urology · 124d
Cleared Jul 21, 2017
Fujifilm Duodenoscope Model ED-530XT
K152257 · FDT
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 711d
Cleared Jul 20, 2017
GelPOINT Path Transanal Access Platform
K171701 · FER
Applied Medical Resources Corp.
Gastroenterology & Urology · 42d
Cleared Jul 20, 2017
DORA Disposable A.V. Fistula Needle Sets
K163025 · FIE
Bain Medical Equipment (Guangzhou)...
Gastroenterology & Urology · 262d
Cleared Jul 12, 2017
Relizorb
K163057 · PLQ
Alcresta Therapeutics, Inc.
Gastroenterology & Urology · 253d
Cleared Jul 07, 2017
Interject Injection Therapy Needle Catheter
K171454 · FBK
Boston Scientific Corporation
Gastroenterology & Urology · 51d
Cleared Jul 07, 2017
Karl Storz UROMAT E.A.S.I.
K162992 · LJH
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 253d
Cleared Jul 07, 2017
Everyway Incontinence Stimulation System
K161349 · KPI
Everyway Medical Instrument Co., Ltd.
Gastroenterology & Urology · 417d
Cleared Jun 28, 2017
Delta III Lithotripter
K170122 · LNS
Dornier Medtech America
Gastroenterology & Urology · 166d
Cleared Jun 22, 2017
EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z...
K171307 · ODE
Endogastric Solutions, Inc.
Gastroenterology & Urology · 50d
Cleared Jun 22, 2017
Tria Firm Ureteral Stent
K163399 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 199d
Not Cleared Jun 21, 2017
Embosphere Microspheres
DEN160040 · NOY
Biosphere Medical, S.A.
Gastroenterology & Urology · 320d
Cleared Jun 19, 2017
Möller Medical Biopsy Needles and Systems
K162588 · KNW
Moller Medical GmbH
Gastroenterology & Urology · 276d
Cleared Jun 16, 2017
Quantum TTC Biliary Balloon Dilator
K171223 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 51d
Cleared Jun 16, 2017
DORA Tubing Sets for Hemodialysis
K161582 · FJK
Bain Medical Equipment (Guangzhou)...
Gastroenterology & Urology · 373d