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
3505–3528 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jul 07, 2004
DOVER RED RUBBER ROBINSON CATHETER
K041243 · KOD
Tyco Healthcare
Gastroenterology & Urology · 57d
Cleared Jul 07, 2004
MODIFICATION TO TRIPTER X-1 COMPACT DUET
K041582 · LNS
Direx Systems Corp.
Gastroenterology & Urology · 23d
Cleared Jul 07, 2004
EXTRACTOR RX RETRIEVAL BALLOON
K041606 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 22d
Cleared Jul 02, 2004
ZILVER BILIARY STENT SYSTEM USW
K040930 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 84d
Cleared Jul 02, 2004
EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER
K041416 · EYC
Deroyal
Gastroenterology & Urology · 36d
Cleared Jul 02, 2004
NXSTAGE SYSTEM ONE
K041424 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 35d
Cleared Jul 02, 2004
H&S-CONDUCTIVITY STANDARD SOLUTION
K041636 · FKH
H & S Technical Services
Gastroenterology & Urology · 15d
Cleared Jul 01, 2004
OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY...
K041494 · FET
Olympus Corporation
Gastroenterology & Urology · 27d
Cleared Jun 28, 2004
BIPRO MODEL SDS-CB200
K033118 · FIN
Medical Solutions International
Gastroenterology & Urology · 272d
Cleared Jun 25, 2004
WILOSN-COOK BILIARY DILATION BALLOON
K040800 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 24, 2004
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
K041370 · FGE
Orbus Medical Technologies
Gastroenterology & Urology · 31d
Cleared Jun 23, 2004
CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143
K040494 · NEZ
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 118d
Cleared Jun 21, 2004
CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
K040413 · FGE
Cordis Europa, N.V.
Gastroenterology & Urology · 124d
Cleared Jun 10, 2004
HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED...
K033477 · MJC
Rochester Medical Corp.
Gastroenterology & Urology · 220d
Cleared Jun 10, 2004
DISPOSABLE OVERTUBE
K040836 · FED
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 71d
Cleared Jun 07, 2004
FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM
K040048 · FDA
Fujinon, Inc.
Gastroenterology & Urology · 147d
Cleared May 26, 2004
MODIFICATION TO NXSTAGE SYSTEM ONE
K040696 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 70d
Cleared May 25, 2004
ECONOLITH E3000, MODEL 3000 (SW-6)
K040461 · LNS
Medispec, Ltd.
Gastroenterology & Urology · 92d
Cleared May 24, 2004
POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE
K040255 · KDI
Gambro Renal Products, Inc.
Gastroenterology & Urology · 110d
Cleared May 20, 2004
WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH
K040324 · FDX
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 100d
Cleared May 20, 2004
SLIP UROLOGY CATHETER
K040519 · EZD
Percutaneous Systems, Inc.
Gastroenterology & Urology · 83d
Cleared May 20, 2004
SLIP UROLOGY INTRODUCER SHEATH
K040520 · KNY
Percutaneous Systems, Inc.
Gastroenterology & Urology · 83d
Cleared May 19, 2004
TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR
K041006 · MSD
Kendall
Gastroenterology & Urology · 30d
Cleared May 18, 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
K040736 · MSD
Boston Scientific Corp
Gastroenterology & Urology · 57d