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
2617–2640 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Aug 27, 2010
GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,...
K101199 · KNT
Maquet Critical Care AB
Gastroenterology & Urology · 120d
Cleared Aug 27, 2010
BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
K101832 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 57d
Cleared Aug 23, 2010
EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS,...
K102082 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 28d
Cleared Aug 17, 2010
LO-50 LED LIGHT SOURCE
K102167 · NTN
Fiberoptics Technology, Inc.
Gastroenterology & Urology · 15d
Cleared Aug 13, 2010
2008 HEMODIALYSIS SORBENT SYSTEM
K093362 · FKT
Renal Solutions, Inc.
Gastroenterology & Urology · 289d
Cleared Aug 05, 2010
ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA,...
K101298 · OCZ
Endochoice, Inc.
Gastroenterology & Urology · 87d
Cleared Aug 03, 2010
NEOMED ENTERAL ONLY EXTENSION SET
K100288 · KNT
Neomed, Inc.
Gastroenterology & Urology · 183d
Cleared Aug 03, 2010
COLONOSCOPE/SIGMOIDOSCOPE SHEATHES
K100966 · FDF
Sheathing Technologies, Inc.
Gastroenterology & Urology · 117d
Cleared Aug 02, 2010
TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL...
K093079 · KNS
Hobbs Medical, Inc.
Gastroenterology & Urology · 306d
Cleared Jul 29, 2010
GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H
K093608 · FIP
Gambro Renal Products, Inc.
Gastroenterology & Urology · 251d
Cleared Jul 29, 2010
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K101261 · NFK
C.R. Bard, Inc.
Gastroenterology & Urology · 85d
Cleared Jul 27, 2010
NAVIAID ICVI DEVICE
K101191 · FDF
Smart Medical Systems , Ltd.
Gastroenterology & Urology · 90d
Cleared Jul 23, 2010
MINI-TONG
K101101 · OCW
Mini Lap Technologies, Inc.
Gastroenterology & Urology · 94d
Cleared Jul 23, 2010
GUARDIAN CONNECTION
K101214 · FPD
Maulin Medical, LLC
Gastroenterology & Urology · 84d
Cleared Jul 23, 2010
ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
K101314 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 73d
Cleared Jul 23, 2010
ADVANIX DOUBLE PIGTAIL BILIARY STENT
K101786 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 28d
Cleared Jul 19, 2010
DIRECT PERORAL CHOLANGIOSCOPY BALLOON
K101095 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 16, 2010
WATER BOTTLE CAP SYSTEM
K101146 · FEQ
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 84d
Cleared Jul 15, 2010
THD BANDY
K093497 · FHN
Thd Spa
Gastroenterology & Urology · 245d
Cleared Jul 14, 2010
OLYMPUS CF TYPE Y0023-L, Y0023I
K101053 · FDF
Olympus Medical Systems Corporation
Gastroenterology & Urology · 90d
Cleared Jul 09, 2010
VENOFER PUMP
K093964 · KDI
Renal Solutions, Inc.
Gastroenterology & Urology · 197d
Cleared Jul 02, 2010
MEDLINE PVC URETHRAL CATHETER
K100302 · EZD
Medline Industries, Inc.
Gastroenterology & Urology · 149d
Cleared Jul 02, 2010
EVIS EXERAII 180 SYSTEM
K100584 · NWB
Olympus Medical Systems Corporation
Gastroenterology & Urology · 122d
Cleared Jul 01, 2010
WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON,...
K100275 · FAS
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 150d