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
8473–8496 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Mar 22, 1984
JAKOBI SURG. INSTRUMENTS #3 21/22/24
K834192 · KOA
Imm Enterprises , Ltd.
Gastroenterology & Urology · 122d
Cleared Mar 22, 1984
BILIARY INDWELLING STENT
K834351 · FGE
Hobbs Medical, Inc.
Gastroenterology & Urology · 100d
Cleared Mar 22, 1984
URETERAL DOUBLE PIGTAIL STENT
K834401 · FAD
Hobbs Medical, Inc.
Gastroenterology & Urology · 99d
Cleared Mar 22, 1984
BSM 2000 DIALYSIS MACHINE
K840062 · KOC
Organon Teknika Corp.
Gastroenterology & Urology · 73d
Cleared Mar 22, 1984
SERENITY CONTOURED ABSORBENT SHIELDS
K840679 · EYQ
Johnson & Johnson Consumer Products,...
Gastroenterology & Urology · 36d
Cleared Mar 22, 1984
SECURE W/25MM DIAM. SHEATH & ADHESIVE
K840702 · KNX
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 34d
Cleared Mar 22, 1984
SECURE W/30MM DIAM, SHEATH & ADHESIVE
K840703 · KNX
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 34d
Cleared Mar 22, 1984
SECURE W/35MM DIAM, SHEATH/ADHESIVE
K840704 · KNX
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 34d
Cleared Mar 22, 1984
NEEDLE CATHETER JEJUNOSTOMY REPAIR KIT
K840936 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 17d
Cleared Mar 20, 1984
PROBES, VARIOUS
K841003 · KOA
Premier Dental Products Co.
Gastroenterology & Urology · 11d
Cleared Mar 20, 1984
ALU-KART
K841178
Micro Encapsulation Tech.
Gastroenterology & Urology
Cleared Mar 20, 1984
HEMO-KART
K841179
Micro Encapsulation Tech.
Gastroenterology & Urology
Cleared Mar 20, 1984
DIA-KART
K841180
Micro Encapsulation Tech.
Gastroenterology & Urology
Cleared Mar 16, 1984
URETHRAL CATH. TRAY W/BAG
K840292 · KNX
Corpak Co.
Gastroenterology & Urology · 52d
Cleared Mar 12, 1984
MONOJECT SOFT TISSUE BIOPSY NEEDLE
K834249 · FCG
Sherwood Medical Co.
Gastroenterology & Urology · 96d
Cleared Mar 12, 1984
MILLEREISEN CURVED BIOPSY NEEDLE
K840157 · FCG
Preventive Medicine Institute
Gastroenterology & Urology · 59d
Cleared Mar 12, 1984
WESTERMAN-JENSEN BIOPSY NEEDLE
K840168 · FCG
Popper & Sons, Inc.
Gastroenterology & Urology · 56d
Cleared Mar 12, 1984
MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE
K840354 · FCG
Sherwood Medical Co.
Gastroenterology & Urology · 46d
Cleared Mar 07, 1984
FOLEY CATHETERIZATION TRAY-VARIOUS
K832363 · KOD
Inmed Corp.
Gastroenterology & Urology · 233d
Cleared Mar 05, 1984
ABSORBENT INCONTINENT PADS & BRIEFS
K834359 · EYQ
Weyerhaeuser Co.
Gastroenterology & Urology · 83d
Cleared Mar 05, 1984
HEMOCATH REPAIR KIT
K840424 · KNZ
Quinton, Inc.
Gastroenterology & Urology · 33d
Cleared Mar 02, 1984
DISPOS. ENTERIC FEEDING TUBES W/SAFE-T
K833687 · KNT
Superior Plastic Products Corp.
Gastroenterology & Urology · 123d
Cleared Feb 21, 1984
BIOREM 3000 & 4000
K833454 · LIL
Biorem
Gastroenterology & Urology · 146d
Cleared Feb 21, 1984
FLEXIBLE LIQUID LIGHT GUIDE
K834487 · FFS
Endo Lase, Inc.
Gastroenterology & Urology · 70d