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
4921–4944 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Oct 24, 1997
CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP
K970595 · FEN
Circon Video
Gastroenterology & Urology · 248d
Cleared Oct 24, 1997
TRI TALON RETRIEVAL FORCEPS
K973071 · OCZ
Medical Engineering Laboratory, Inc.
Gastroenterology & Urology · 67d
Cleared Oct 22, 1997
AHCS HEMOPERFUSION SYSTEM
K971015 · FLD
American Health Care Systems, Inc.
Gastroenterology & Urology · 216d
Cleared Oct 21, 1997
FEMASSIST URINARY DEVICE
K963858 · MNG
Insight Medical Corp.
Gastroenterology & Urology · 391d
Cleared Oct 21, 1997
CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH)
K971897 · LFK
Medron, Inc.
Gastroenterology & Urology · 152d
Cleared Oct 20, 1997
ISLAND BIOSURGICAL INC. BNS KIT #1 & #2
K973022 · OTN
Island Biosurgical, Inc.
Gastroenterology & Urology · 67d
Cleared Oct 16, 1997
BARD RAPIDFIRE MULTIPLE BAND LIGATOR
K971137 · MND
C.R. Bard, Inc.
Gastroenterology & Urology · 202d
Cleared Oct 16, 1997
REJOYN PENILE SUPPORT SYSTEM
K971576 · LKY
American Medtech
Gastroenterology & Urology · 174d
Cleared Oct 16, 1997
BARD ENDOSCOPIC OVERTUBE (#000307)
K973500 · FED
C.R. Bard, Inc.
Gastroenterology & Urology · 30d
Cleared Oct 10, 1997
ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE
K972964 · KOE
Atrion Medical Products, Inc.
Gastroenterology & Urology · 60d
Cleared Oct 10, 1997
INSULATOR WIRE GUIDE
K972977 · KNY
Cook Urological, Inc.
Gastroenterology & Urology · 60d
Cleared Oct 09, 1997
MRI COMPATIBLE BIOPSY NEEDLES
K962977 · KNW
Manan Medical Products, Inc.
Gastroenterology & Urology · 435d
Cleared Oct 09, 1997
CRE BALLOON DILATATION CATHETER
K971320 · KNQ
Boston Scientific Corp
Gastroenterology & Urology · 182d
Cleared Oct 08, 1997
MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE
K972926 · FBN
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 61d
Cleared Oct 07, 1997
RUSCH BRILLANT BALLOON CATHETER
K971643 · EZL
Rusch Intl.
Gastroenterology & Urology · 155d
Cleared Oct 07, 1997
OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN...
K972825 · FGE
Cordis Corp.
Gastroenterology & Urology · 90d
Cleared Oct 03, 1997
VTU-1 VACUUM ERECTION SYSTEM
K971257 · LKY
Mckenna & Cuneo
Gastroenterology & Urology · 182d
Cleared Oct 01, 1997
HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE...
K972579 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 83d
Cleared Sep 30, 1997
ASAHI AM-R SERIES DIALYZERS
K970650 · MSE
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 222d
Cleared Sep 29, 1997
RELIANT CHARGER
K971768 · LKY
Walling Medical Equipment Co.
Gastroenterology & Urology · 139d
Cleared Sep 29, 1997
NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET
K972731 · KDJ
Klein-Baker Medical, Inc.
Gastroenterology & Urology · 69d
Cleared Sep 29, 1997
JIMMY JOHN III RECTAL NOZZLE
K973256 · KPL
Colon Therapeutics
Gastroenterology & Urology · 35d
Cleared Sep 26, 1997
COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET
K970253 · KDI
Gambro Healthcare
Gastroenterology & Urology · 247d
Cleared Sep 26, 1997
RAPPORT V.T.D.
K971443 · LKY
Owen Mumford USA, Inc.
Gastroenterology & Urology · 158d