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
8641–8664 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Aug 12, 1983
GASTROSTOMY FEEDING SET
K831631 · KNT
Plasco, Inc.
Gastroenterology & Urology · 84d
Cleared Aug 12, 1983
AXIOM FEEDING GASTRO TUBE
K831823 · KNT
Axiom Medical, Inc.
Gastroenterology & Urology · 66d
Cleared Aug 12, 1983
FEEDING TUBE PLACEMENT STYLET
K831840 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 66d
Cleared Aug 12, 1983
BLOOD TUBING SET
K832103 · KOC
Lee Medical Intl., Inc.
Gastroenterology & Urology · 50d
Cleared Aug 11, 1983
MORHEL CLOSED URINARY DRAINAGE SET
K831622 · KNX
Morhel Mexicana
Gastroenterology & Urology · 83d
Cleared Aug 11, 1983
EMPTY DIALYSATE CONTAINER
K831689 · FKK
Delmed, Inc.
Gastroenterology & Urology · 79d
Cleared Aug 11, 1983
SURGITEK PERCUTANEOUS ARNEGRADE SILITEK
K831857 · FAD
Medical Engineering Corp.
Gastroenterology & Urology · 63d
Cleared Aug 11, 1983
PENTAX FG-34JA GASTROFIBERSCOPE
K832007 · FDS
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 49d
Cleared Aug 10, 1983
FOLEY-TEMP
K831567 · KOD
Mallinckrodt Critical Care
Gastroenterology & Urology · 86d
Cleared Aug 08, 1983
COMPUDIAL/KP-1
K831132 · LIF
Computer Dialysis Systems, Inc.
Gastroenterology & Urology · 124d
Cleared Aug 08, 1983
PRESSURE MONITOR & CONTROL UNIT APC-02A
K831402 · KXM
Parker Hannifin Corp.
Gastroenterology & Urology · 98d
Cleared Aug 08, 1983
AMS MALLEABLE PENILE PROSTHESIS
K831660 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 77d
Cleared Aug 08, 1983
URINE BAG SYSTEM
K831796 · KNX
I M, Inc.
Gastroenterology & Urology · 66d
Cleared Aug 08, 1983
GAMMA STERILIZED CAPILLARY FLOW DIALYZ
K831940 · FKQ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 53d
Cleared Aug 08, 1983
IMPROVED SILICATH SILICONE ELASTOMER
K832165 · KOD
Travenol Laboratories, S.A.
Gastroenterology & Urology · 34d
Cleared Aug 01, 1983
PENTAX FD-34A DUODENOFIBERSCOPE
K832006 · FDT
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 39d
Cleared Jul 26, 1983
COAXIAL BALLOON URETHRAL DILATOR
K831384 · FAH
Thomas J. Fogarty, M.D.
Gastroenterology & Urology · 89d
Cleared Jul 19, 1983
COLOSTOMY BAG
K830841 · EXB
C & D Colostomy Pad Corp.
Gastroenterology & Urology · 124d
Cleared Jul 19, 1983
NEONATAL NASOGASTRIC FEEDING TUBE-
K831328 · KNT
Corpak Medsystems
Gastroenterology & Urology · 85d
Cleared Jul 19, 1983
INFUSION PUMP
K831953 · FIR
Cryosan, Inc.
Gastroenterology & Urology · 34d
Cleared Jul 19, 1983
EXTERNAL INCONTINENCE CATHETER TRAVEL
K832106 · KNX
Plasco, Inc.
Gastroenterology & Urology · 20d
Cleared Jul 19, 1983
LEG BAG EXTENTION TUBE-STERILE
K832107 · KNX
Plasco, Inc.
Gastroenterology & Urology · 20d
Cleared Jul 18, 1983
VIVONEX TUNGSTEN TIP TUBE-MONOFILA-
K831970 · KNT
Norwich Eaton Pharmaceuticals, Inc.
Gastroenterology & Urology · 28d
Cleared Jul 18, 1983
STOMACH TUBE LEVIN TUBE
K831974 · KNT
Medline Industries, Inc.
Gastroenterology & Urology · 28d