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
6625–6648 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Mar 19, 1991
HOT BIOPSY FORCEPS
K905088 · KGE
Esco Precision, Inc.
Gastroenterology & Urology · 125d
Cleared Mar 19, 1991
ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE
K905282 · GCT
Frantz Medical Development, Ltd.
Gastroenterology & Urology · 116d
Cleared Mar 19, 1991
FLEXIFLO SACKS-VINE GASTROSTOMY KITS
K910332 · KNT
Abbott Laboratories
Gastroenterology & Urology · 53d
Cleared Mar 19, 1991
SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE
K910768 · FGE
Surgitek Medical Engineering Corp.
Gastroenterology & Urology · 25d
Cleared Mar 15, 1991
BALLOON CATHETERS
K904669 · FGE
Olympus Corp.
Gastroenterology & Urology · 151d
Cleared Mar 15, 1991
ACETATE CONCENTRATES FOR HEMODIALYSIS
K905021 · KPO
Medical Components, Inc.
Gastroenterology & Urology · 128d
Cleared Mar 13, 1991
SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT
K905289 · FAD
Medical Engineering Corp.
Gastroenterology & Urology · 107d
Cleared Mar 11, 1991
LOOP RETRIEVER
K910603 · FFL
Annex Medical, Inc.
Gastroenterology & Urology · 27d
Cleared Mar 08, 1991
HIGH SPEED CORE CUT BIOPSY GUN
K905556 · FCG
Uni-Quatro Industries Canada, Inc.
Gastroenterology & Urology · 87d
Cleared Mar 08, 1991
CCC CROWN-CORE-CUT-NEEDLE
K905557 · KNW
Uni-Quatro Industries Canada, Inc.
Gastroenterology & Urology · 87d
Cleared Mar 07, 1991
BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD
K902588 · KOC
Gambro-Hospal, Inc.
Gastroenterology & Urology · 268d
Cleared Mar 06, 1991
CONVATEC ABSORBENT BANDAGE
K904233 · EXE
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 182d
Cleared Mar 06, 1991
NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY
K905181 · EZN
Meadox Surgimed, Inc.
Gastroenterology & Urology · 107d
Cleared Mar 05, 1991
SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8)
K904793 · FGB
Surgitek
Gastroenterology & Urology · 133d
Cleared Mar 05, 1991
SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16)
K904797 · FBO
Surgitek
Gastroenterology & Urology · 133d
Cleared Mar 01, 1991
NEEDLE, DIALYSIS
K902564 · FIE
Gainor Medical Europe, Ltd.
Gastroenterology & Urology · 263d
Cleared Feb 25, 1991
EER ERECTION ENHANCED RESPONDER
K904406 · LKY
Eer, Inc.
Gastroenterology & Urology · 154d
Cleared Feb 19, 1991
FST CATH-UD CATHETER
K905641 · FEN
Fiberoptic Sensor Technlogies, Inc.
Gastroenterology & Urology · 63d
Cleared Feb 13, 1991
TUBE DECLOGGER
K905164 · KNT
Nova Design Technologies, Ltd.
Gastroenterology & Urology · 89d
Cleared Feb 13, 1991
BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS
K905707 · FGE
Baxter Healthcare Corp
Gastroenterology & Urology · 54d
Cleared Feb 13, 1991
AVD INTIMAX (TM) BILIARY CATHETER
K910006 · FGE
Applied Vascular
Gastroenterology & Urology · 42d
Cleared Feb 12, 1991
COBE CENTRY 2 BICART OPTION KIT
K905793 · FKP
Cobe Laboratories, Inc.
Gastroenterology & Urology · 47d
Cleared Feb 11, 1991
VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD)
K904987 · KNW
Vibronics
Gastroenterology & Urology · 96d
Cleared Feb 11, 1991
COBE CENTRYSYSTEM 3 BICART OPTION KIT
K905388 · FKP
Cobe Laboratories, Inc.
Gastroenterology & Urology · 73d