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
8857–8880 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Sep 02, 1982
NEPHROSOL
K822244 · KOC
Dialysis Systems, Inc.
Gastroenterology & Urology · 37d
Cleared Sep 02, 1982
NASO-GARD NASOGASTRIC TUBE HOLDER
K822443 · KNT
American Pharmaseal Div. Ahsc
Gastroenterology & Urology · 17d
Cleared Aug 30, 1982
STERILE FOLEY CATHETERIZATION KITS
K821979 · KNX
Medical Devices, Inc.
Gastroenterology & Urology · 55d
Cleared Aug 30, 1982
HPF 100,200,300 CAPILLARY FLOW DIALYZ
K822485 · FKQ
Erika, Inc.
Gastroenterology & Urology · 13d
Cleared Aug 27, 1982
ENDOSCOPIC SCLEROTHERAPY BALLOON
K821999 · GCP
Retech
Gastroenterology & Urology · 51d
Cleared Aug 27, 1982
BIOREM 2000
K822099 · LIL
Biorem
Gastroenterology & Urology · 42d
Cleared Aug 27, 1982
ENDOSCOPIC SPONGE CARRIER
K822194 · FGS
Kelleher Corp.
Gastroenterology & Urology · 35d
Cleared Aug 27, 1982
TS-000 ARTERIOVENOUS BLOOD TUBING SET
K822283 · KOC
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 28d
Cleared Aug 27, 1982
ST. MARK'S RECTAL BIOPSY FORCEPS
K822401 · KOA
Keymed, Inc.
Gastroenterology & Urology · 17d
Cleared Aug 25, 1982
STERILE URETHRAL CATHETERIZATION SET
K821978 · KNX
Medical Devices, Inc.
Gastroenterology & Urology · 50d
Cleared Aug 20, 1982
PIGTAIL STENTS
K821819 · FGE
American Endoscopy, Inc.
Gastroenterology & Urology · 60d
Cleared Aug 20, 1982
ELECTRIC CORD FOR ENDOSCOPE
K822254 · FFZ
Kelleher Corp.
Gastroenterology & Urology · 22d
Cleared Aug 16, 1982
LUNDIA 10-5 N PARALLEL FLOW DIALYZER
K822049 · KOC
Gambro, Inc.
Gastroenterology & Urology · 35d
Cleared Aug 16, 1982
ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE
K822225 · KOC
Erika, Inc.
Gastroenterology & Urology · 20d
Cleared Aug 16, 1982
ERIKA NEGATIVE PRESSURE VENOUS BLOOD LIN
K822226 · KOC
Erika, Inc.
Gastroenterology & Urology · 20d
Cleared Aug 16, 1982
DIANEAL SOLUTION EXCHANGE DEVICE #5C4193
K822361 · FKX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 10d
Cleared Aug 12, 1982
CF 1211 CAPILLARY FLOW DIALYZER CODE
K822395 · FJH
Travenol Laboratories, S.A.
Gastroenterology & Urology · 1d
Cleared Aug 10, 1982
THE ARTIFICIAL URINARY SPHINCTER
K821627 · FAG
American Medical Systems, Inc.
Gastroenterology & Urology · 69d
Cleared Aug 10, 1982
THE INFLATABLE PENILE PROSTHESIS
K821628 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 69d
Cleared Aug 10, 1982
SURGITEK PERCUTANEOUS NEPHROST. STENT
K821776 · LJE
Medical Engineering Corp.
Gastroenterology & Urology · 54d
Cleared Aug 10, 1982
PIGTAIL NASAL CATHETERS
K821817 · FGE
American Endoscopy, Inc.
Gastroenterology & Urology · 50d
Cleared Aug 10, 1982
CONPHAR SILICONE FEEDING TUBE
K821825 · KNT
Conphar, Inc.
Gastroenterology & Urology · 49d
Cleared Aug 10, 1982
ASSURE-MALE EXTERNAL INCONTINCE CATHETER
K821848 · KNX
Medical Design & Manufacturing Corp.
Gastroenterology & Urology · 49d
Cleared Aug 10, 1982
PENTAX CHOLEDOCHOFIBERSCOPE, #FCD-15A
K821974 · FBN
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 39d