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
5953–5976 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Apr 07, 1994
CMI E-Z FLO BULB P.N. 701
K932128 · FFY
Columbia Medical & Surgical, Inc.
Gastroenterology & Urology · 339d
Cleared Apr 06, 1994
ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES
K936198 · GCT
Carl Zeiss, Inc.
Gastroenterology & Urology · 98d
Cleared Apr 05, 1994
AKCESS-CATH
K925818 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 504d
Cleared Apr 01, 1994
SCHUSTER DISPOSABLE BALLOON PROBE
K931175 · FAP
Sandhill Scientific, Inc.
Gastroenterology & Urology · 388d
Cleared Apr 01, 1994
MICROINFUSOR
K932306 · FFX
Sandhill Scientific, Inc.
Gastroenterology & Urology · 325d
Cleared Apr 01, 1994
GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE
K933173 · FAS
Greenwald Surgical Co., Inc.
Gastroenterology & Urology · 276d
Cleared Apr 01, 1994
GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE
K933174 · FAS
Greenwald Surgical Co., Inc.
Gastroenterology & Urology · 276d
Cleared Apr 01, 1994
GREENWALD CONTROL TIP URETEROSCOPIC ELECTRODE
K933175 · FAS
Greenwald Surgical Co., Inc.
Gastroenterology & Urology · 276d
Cleared Mar 31, 1994
MENLO CARE URINARY DIVERSION STENT
K933941 · FAD
Menlo Care, Inc.
Gastroenterology & Urology · 231d
Cleared Mar 30, 1994
GRANULYTE DIALYSATE CONCENTRATE
K922005 · KPO
Fresenius USA, Inc.
Gastroenterology & Urology · 700d
Cleared Mar 30, 1994
CD HOME DIALYSERVICE HEMODIALYSIS TRAY
K925654 · KOC
Cd Medical, Inc.
Gastroenterology & Urology · 506d
Cleared Mar 30, 1994
CATHEJELL S STERILE LUBRICATING JELLY
K935548 · FHX
Pharmazeutische Fabrik Montavit GmbH
Gastroenterology & Urology · 133d
Cleared Mar 30, 1994
TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS
K940203 · FEN
Life-Tech Intl., Inc.
Gastroenterology & Urology · 76d
Cleared Mar 28, 1994
ABBOTT SMART CAP
K921818 · KDJ
Abbott Laboratories
Gastroenterology & Urology · 712d
Cleared Mar 28, 1994
4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS
K933109 · KOD
Boston Pacific Medical, Inc.
Gastroenterology & Urology · 276d
Cleared Mar 28, 1994
GLOBAL MEDICAL CUTTING BIOPSY NEEDLE
K934256 · FCG
Global Medical Prods, Inc.
Gastroenterology & Urology · 209d
Cleared Mar 28, 1994
WILSON-COOK BALLOON INFLATION DEVICE
K936168 · KNT
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 95d
Cleared Mar 25, 1994
4 SURE TM ENTERAL FEEDING BAG
K922402 · FPD
Boston Pacific Medical, Inc.
Gastroenterology & Urology · 673d
Cleared Mar 25, 1994
FOGLESS
K923843 · OCT
Sorex Medical
Gastroenterology & Urology · 602d
Cleared Mar 24, 1994
ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY
K913468 · LFJ
Cook, Inc.
Gastroenterology & Urology · 962d
Cleared Mar 22, 1994
COAXIAL BIOPSY NEEDLE
K936194 · FCG
Bard Gynecology and Radiology
Gastroenterology & Urology · 83d
Cleared Mar 22, 1994
GAMBRO BICART 720G
K940601 · KPO
C.G.H. Medical, Inc.
Gastroenterology & Urology · 40d
Cleared Mar 21, 1994
FLUSHING IRRIGATION SET
K923497 · KDH
Orion Life Systems, Inc.
Gastroenterology & Urology · 614d
Cleared Mar 17, 1994
FRANGI-CATH SAFE-RELEASE(TM) CONNECTOR
K932809 · EZL
Excalibur Engineering Care of Rms, Inc.
Gastroenterology & Urology · 281d