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
7993–8016 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Oct 18, 1985
ERIKA ARTERIAL LINE 03-9837-0
K853962 · FJK
National Medical Care, Medical...
Gastroenterology & Urology · 23d
Cleared Oct 17, 1985
E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY
K852535 · KNT
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 125d
Cleared Oct 17, 1985
COONS GASTROSTICK SYSTEM
K852552 · KNT
Medi-Tech, Inc.
Gastroenterology & Urology · 122d
Cleared Oct 17, 1985
LABORIE URODYNAMICS PROCESSOR
K852856 · FAP
Tridak Division of Indicon, Inc.
Gastroenterology & Urology · 104d
Cleared Oct 17, 1985
AMERICAN DILATATION SYSTEM
K853274 · KNQ
American Endoscopy, Inc.
Gastroenterology & Urology · 73d
Cleared Oct 17, 1985
VELCRO FISTULA PRESSURE CLAMPS
K853536 · KXM
Cp Medical
Gastroenterology & Urology · 55d
Cleared Oct 17, 1985
KAY PLUS ADULT DIAPER
K853740 · EYQ
Beghin_Say Intl., Inc.
Gastroenterology & Urology · 41d
Cleared Oct 17, 1985
COBE REN NEW-D DISPENSING KIT
K853817 · LIF
Cobe Laboratories, Inc.
Gastroenterology & Urology · 35d
Cleared Oct 04, 1985
BARD-PARKER BILIARY BALLOON CATHETER
K852293 · FGE
Bd Becton Dickinson Vacutainer...
Gastroenterology & Urology · 128d
Cleared Oct 04, 1985
DISPOSABLE, STERILE BIOPSY PUNCH
K853104 · FCI
August C. Stiefel Research Institute,...
Gastroenterology & Urology · 73d
Cleared Oct 04, 1985
URODYN 1000
K853119 · FFO
Dantec Electronics, Inc.
Gastroenterology & Urology · 71d
Cleared Oct 04, 1985
FEEDING UNITS & TUBES
K853288 · KNT
I M, Inc.
Gastroenterology & Urology · 38d
Cleared Oct 04, 1985
RIGID ENDOSCOPE
K853514 · GCM
American Edwards Laboratories
Gastroenterology & Urology · 43d
Cleared Oct 04, 1985
ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH
K853530 · FDX
E-Z-Em, Inc.
Gastroenterology & Urology · 42d
Cleared Oct 04, 1985
TRAVENOL CAPD Y SET 5C4354
K853550 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 39d
Cleared Oct 04, 1985
COLORADO MEDICAL MODEL CTM-3000
K853735 · FIZ
Colorado Medical, Inc.
Gastroenterology & Urology · 28d
Cleared Sep 20, 1985
THE KENDALL URINARY OUTPUT MONITOR
K852083 · FFO
The Kendal Co.
Gastroenterology & Urology · 130d
Cleared Sep 20, 1985
KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP
K852084 · KOD
The Kendal Co.
Gastroenterology & Urology · 130d
Cleared Sep 20, 1985
IDECAP DIALYZER
K852764 · FJH
Trans-National Trade Development Corp.
Gastroenterology & Urology · 84d
Cleared Sep 20, 1985
DAVOL RETRIEVAL BALLOON CATHETER
K853543 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 25d
Cleared Sep 17, 1985
REVIVE SYSTEM
K844445 · LKY
Revive Systems Corp.
Gastroenterology & Urology · 305d
Cleared Sep 12, 1985
PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE
K853207 · KOD
American Pharmaseal Div. Ahsc
Gastroenterology & Urology · 43d
Cleared Sep 12, 1985
OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE
K853486 · FGA
Olympus Corp.
Gastroenterology & Urology · 23d
Cleared Sep 12, 1985
MINIFILTER HEMOFILTER
K853510 · KDI
Amicon, Inc.
Gastroenterology & Urology · 22d