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
6241–6264 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Nov 23, 1992
YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES
K922821 · EZL
Yellow Springs Instrument Co., Inc.
Gastroenterology & Urology · 165d
Cleared Nov 23, 1992
CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES
K924271 · FCG
Core Medical, Inc.
Gastroenterology & Urology · 91d
Cleared Nov 16, 1992
E-Z-EM ENTEROCLYSIS CATHETER SET
K911349 · EZK
E-Z-Em, Inc.
Gastroenterology & Urology · 600d
Cleared Nov 16, 1992
OXFORD OPTRONIX MPM 3S
K914397 · FTI
Dia-Stron, Ltd.
Gastroenterology & Urology · 412d
Cleared Nov 16, 1992
CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE
K915725 · FHO
Clarus Medical Systems, Inc.
Gastroenterology & Urology · 332d
Cleared Nov 10, 1992
MALECOT-NEPHROSTOMY TAMPONADE CATHETER
K915209 · LJE
Cook Urological, Inc.
Gastroenterology & Urology · 358d
Cleared Oct 30, 1992
BARD BIOPSY FORCEPS
K922086 · GCL
C.R. Bard, Inc.
Gastroenterology & Urology · 179d
Cleared Oct 30, 1992
NASOGRASTRIC TUBBE HOLDER
K922209 · KNT
Innovative Medical Design Corp.
Gastroenterology & Urology · 171d
Cleared Oct 30, 1992
CONVEEN(R) LEG BAG(500 ML)
K924406 · FAQ
Coloplast A/S
Gastroenterology & Urology · 66d
Cleared Oct 28, 1992
120 FR OPTILUME PROSTATE BALLOON DILATOR
K920551 · KOE
American Medical Systems, Inc.
Gastroenterology & Urology · 265d
Cleared Oct 28, 1992
EVACUATOR, GASTRO-UROLOGY
K921088 · KQT
Northgate Technologies, Inc.
Gastroenterology & Urology · 236d
Cleared Oct 28, 1992
EVACUATOR, GASTRO-UROLOGY
K921451 · KQT
Northgate Technologies, Inc.
Gastroenterology & Urology · 216d
Cleared Oct 28, 1992
FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM
K921690 · FAM
Vision-Sciences, Inc.
Gastroenterology & Urology · 203d
Cleared Oct 28, 1992
ENTRAC URETERAL BALLOON DILATION CATHETERS
K921839 · EZN
American Medical Systems, Inc.
Gastroenterology & Urology · 194d
Cleared Oct 26, 1992
LOPEZ VALVE WITH NG SUMP TUBE
K921104 · FEG
Icu Medical, Inc.
Gastroenterology & Urology · 231d
Cleared Oct 23, 1992
INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR
K924451 · FGE
Interventional Therapeutics Corp.
Gastroenterology & Urology · 52d
Cleared Oct 20, 1992
DISLODGER, STONE, BASKET, URETERAL, METAL
K924027 · FFL
Annex Medical, Inc.
Gastroenterology & Urology · 70d
Cleared Oct 20, 1992
NICKI, MODEL NUMBER USD-NK-UP1
K924086 · FAP
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 68d
Cleared Oct 13, 1992
GRICE SOFT TISSUE BIOPSY KIT
K922161 · KNW
Ideal Medical, Inc.
Gastroenterology & Urology · 159d
Cleared Oct 13, 1992
COX DISPOSABLE POLYPECTOMY SNARES
K923671 · FDI
Cox Medical Ent., Inc.
Gastroenterology & Urology · 83d
Cleared Oct 08, 1992
BARD 7 FR. FIBER OPTIC ASSEMBLY
K923545 · FGB
C.R. Bard, Inc.
Gastroenterology & Urology · 84d
Cleared Oct 05, 1992
DDV LIGATOR
K921304 · KOA
North American Medical, Inc.
Gastroenterology & Urology · 208d
Cleared Oct 05, 1992
SYSTEM 3000 XENON VIDEOLAP LIGHT
K923210 · GCT
Cabot Medical Corp.
Gastroenterology & Urology · 96d
Cleared Oct 02, 1992
RADIFOCUS GUIDE WIRE M
K923607 · KOD
Terumo Medical Corp.
Gastroenterology & Urology · 78d