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
9361–9384 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Apr 08, 1980
GAMBRO AK-10-UDM-10-A ULTRADIFFUSION
K800425 · FKP
Gambro, Inc.
Gastroenterology & Urology · 42d
Cleared Apr 08, 1980
RUDD-CLINIC HEMORRHOIDAL FORCEPS
K800441 · KOA
J. Sklar Mfg. Co., Inc.
Gastroenterology & Urology · 40d
Cleared Apr 08, 1980
SUR-FIT UROSTOMY POUCH & URINARY BAG
K800495 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 35d
Cleared Apr 08, 1980
URETHRAL CATHETER
K800505 · KOD
Medi-Craft , Ltd.
Gastroenterology & Urology · 35d
Cleared Apr 08, 1980
FEEDING TUBES
K800507 · KNT
Medi-Craft , Ltd.
Gastroenterology & Urology · 35d
Cleared Apr 08, 1980
STOMACH TUBES
K800508 · KNT
Medi-Craft , Ltd.
Gastroenterology & Urology · 35d
Cleared Apr 08, 1980
RECTAL & HARRIS FLUSH TUBES
K800510 · KNT
Medi-Craft , Ltd.
Gastroenterology & Urology · 35d
Cleared Apr 08, 1980
SUPRAPUBIC TROCAR
K800607 · KOB
G.D. Searle and Co.
Gastroenterology & Urology · 22d
Cleared Apr 08, 1980
STONE DISLODGER
K800608 · FFL
G.D. Searle and Co.
Gastroenterology & Urology · 22d
Cleared Apr 08, 1980
URETHRAL SOUND
K800610 · KOE
G.D. Searle and Co.
Gastroenterology & Urology · 22d
Cleared Apr 08, 1980
BOUGIE A BOULE
K800611 · KOE
G.D. Searle and Co.
Gastroenterology & Urology · 22d
Cleared Mar 25, 1980
ADT DISPOSABLE THIN NEEDLE(SKINNY CHIBA)
K800416 · FCG
A.D.T. Lab Industries
Gastroenterology & Urology · 28d
Cleared Mar 25, 1980
ADT PERCUTANEOUS TRANSHEPATIC DISP. CHOL
K800419 · FCG
A.D.T. Lab Industries
Gastroenterology & Urology · 28d
Cleared Mar 25, 1980
ADT PERCUTANEOUS NON-DISP. NEEDLE
K800420 · FCG
A.D.T. Lab Industries
Gastroenterology & Urology · 28d
Cleared Mar 12, 1980
DMS 3000
K792252 · FKQ
Renal Care Corp.
Gastroenterology & Urology · 125d
Cleared Mar 10, 1980
ELLIK BLADDER EVACUATOR
K800397 · KQT
Sage Products, Inc.
Gastroenterology & Urology · 13d
Cleared Mar 03, 1980
ELECTRONIC PERINEOMETER
K800303 · HIR
Associates IN Biofeedback
Gastroenterology & Urology · 21d
Cleared Feb 28, 1980
FOLEY CATHETER
K800306 · KOD
Abco Dealers, Inc.
Gastroenterology & Urology · 16d
Cleared Feb 28, 1980
IRRIGATION (3-WAY) FOLEY CATHETER
K800307 · KOD
Abco Dealers, Inc.
Gastroenterology & Urology · 16d
Cleared Feb 28, 1980
PEDIATRIC FOLEY CATHETER
K800308 · KOD
Abco Dealers, Inc.
Gastroenterology & Urology · 16d
Cleared Feb 28, 1980
CONCEPT SUCTION COAGULATOR
K800321 · KNS
Concept, Inc.
Gastroenterology & Urology · 16d
Cleared Feb 26, 1980
SURGITEK URINARY DIVERSION STENT
K800109 · FAD
Medical Engineering Corp.
Gastroenterology & Urology · 41d
Cleared Feb 26, 1980
LOGO-NU-WAY
K800186 · KNX
Gary Giancarlo
Gastroenterology & Urology · 28d
Cleared Feb 26, 1980
CF/211 CAPILLARY FLOW DIALYZER, #5M1784
K800221 · FJI
Travenol Laboratories, S.A.
Gastroenterology & Urology · 22d