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
2953–2976 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Mar 20, 2008
SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300
K073227 · MNW
Aiia Communication, Inc.
Gastroenterology & Urology · 126d
Cleared Mar 19, 2008
MEDLINE GASTROSTOMY TUBE
K073718 · KGC
Medline Industries, Inc.
Gastroenterology & Urology · 79d
Cleared Mar 18, 2008
5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05
K072301 · FGE
Ev3, Inc.
Gastroenterology & Urology · 214d
Cleared Mar 18, 2008
EVIS EXERA II 180 SYSTEM
K072957 · NWB
Olympus Medical Systems Corporation
Gastroenterology & Urology · 151d
Cleared Mar 14, 2008
AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)
K073034 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 140d
Cleared Mar 10, 2008
ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE,...
K073484 · ODC
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 06, 2008
SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012
K080171 · KNW
Sanarus Medical, Inc.
Gastroenterology & Urology · 42d
Cleared Mar 05, 2008
ANCHORAGE ACCESS KIT
K073507 · ODC
Epitek, Inc.
Gastroenterology & Urology · 83d
Cleared Mar 05, 2008
LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY
K073552 · FEN
Laborie Medical Technologies, Corp.
Gastroenterology & Urology · 78d
Cleared Mar 05, 2008
COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND...
K080340 · KNT
Novartis Nutrition Corp.
Gastroenterology & Urology · 26d
Cleared Mar 03, 2008
MINITAPE EXTRA URETHRAL SLING
K073647 · OTN
Mpathy Medical Devices, Ltd.
Gastroenterology & Urology · 68d
Cleared Feb 27, 2008
WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM
K073266 · ESW
Boston Scientific Corp
Gastroenterology & Urology · 99d
Cleared Feb 26, 2008
KIMBERLY-CLARK INTRODUCER KITS
K080253 · KGC
Kimberly-Clark Corp.
Gastroenterology & Urology · 26d
Cleared Feb 25, 2008
MINITAPE URETHRAL SLING
K073646 · PAH
Mpathy Medical Devices, Ltd.
Gastroenterology & Urology · 61d
Cleared Feb 21, 2008
AQUA PURE DEIONIZER EXCHANGE SERVICE
K072158 · FIP
Staubach Barror Water Systems, Inc.
Gastroenterology & Urology · 202d
Cleared Feb 21, 2008
NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
K072988 · FIB
Nipro Medical Corporation
Gastroenterology & Urology · 121d
Cleared Feb 06, 2008
SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB,...
K062798 · FGE
Cordis Corp.
Gastroenterology & Urology · 505d
Cleared Feb 04, 2008
PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY
K072908 · KPO
Gambro Renal Products
Gastroenterology & Urology · 115d
Cleared Feb 01, 2008
PRISMAFLEX SYSTEM, VERSION 3.20
K072093 · KDI
Gambro
Gastroenterology & Urology · 186d
Cleared Jan 31, 2008
SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER,...
K071646 · FGE
Idev Technologies, Inc.
Gastroenterology & Urology · 227d
Cleared Jan 30, 2008
PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER
K072538 · LNS
United Medical Systems, Inc.
Gastroenterology & Urology · 145d
Cleared Jan 30, 2008
AMS MINIARC SLING SYSTEM
K073703 · PAH
American Medical Systems, Inc.
Gastroenterology & Urology · 30d
Cleared Jan 29, 2008
SOLCART B
K072760 · KPO
B. Braun Medizintechnologie GmbH
Gastroenterology & Urology · 123d
Cleared Jan 29, 2008
DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS...
K073092 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 89d