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
8521–8544 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Feb 04, 1984
GASTROINTESTINAL SHEATH BRUSH
K834402 · FDX
Hobbs Medical, Inc.
Gastroenterology & Urology · 52d
Cleared Feb 04, 1984
INJECTION NEEDLE
K834403 · FBK
Bobbs Medical, Inc.
Gastroenterology & Urology · 52d
Cleared Feb 04, 1984
ERCP CANNULA
K834414 · ODD
Hobbs Medical, Inc.
Gastroenterology & Urology · 51d
Cleared Feb 04, 1984
TEMPERATURE SENSING FOLEY CATHETER
K834438 · KOD
C.R. Bard, Inc.
Gastroenterology & Urology · 47d
Cleared Feb 04, 1984
COAXIAL BALLOON GASTROESOPHAGEAL DILA
K834451 · KNQ
Thomas J. Fogarty, M.D.
Gastroenterology & Urology · 47d
Cleared Feb 04, 1984
NEPHROSTOMY/BILIARY DRAINAGE BAG
K834476 · LJE
Vertex Medical Corp.
Gastroenterology & Urology · 46d
Cleared Feb 04, 1984
ESKA JONAS SILICON-SILVER PENILE
K834504 · FAE
Dacomed Corp.
Gastroenterology & Urology · 45d
Cleared Feb 04, 1984
RENAFLO AVF SET FOR HEMODIALYSIS
K834510 · KNZ
Renal Systems, Inc.
Gastroenterology & Urology · 45d
Cleared Feb 04, 1984
BARD KARAYA GUM WASHERS
K834575 · EXB
C.R. Bard, Inc.
Gastroenterology & Urology · 37d
Cleared Feb 04, 1984
BIOSPAL (R) 1800S
K834589 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 37d
Cleared Feb 04, 1984
BLOOD TUBING
K834596 · KOC
Renal Systems, Inc.
Gastroenterology & Urology · 36d
Cleared Feb 04, 1984
EXP* 500 PARALLEL PLATE DIALYZER
K840057 · KOC
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 26d
Cleared Feb 04, 1984
SILITEK URINARY DIVERSION STENT
K840059 · FAD
Surgitek
Gastroenterology & Urology · 26d
Cleared Feb 04, 1984
EXP* 700 PARALLEL PLATE DIALYZER
K840146 · KOC
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 22d
Cleared Feb 04, 1984
SUR-FIT UROSTOMY POUCH W/ACCUSEAL
K840166 · EXB
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 19d
Cleared Jan 30, 1984
COMFEEL PASTE
K833565 · EXB
Coloplast A/S
Gastroenterology & Urology · 110d
Cleared Jan 30, 1984
COLOPLAST BABY URINE COLLECTORS
K833570 · KNX
Coloplast A/S
Gastroenterology & Urology · 110d
Cleared Jan 30, 1984
STERILE DRAINAGE SYSTEM
K833571 · EXB
Coloplast A/S
Gastroenterology & Urology · 110d
Cleared Jan 25, 1984
PREPACELL THIN NEEDLE ASPIRATION TRAY
K833719 · KOD
Applied Medical Devices, Inc.
Gastroenterology & Urology · 93d
Cleared Jan 23, 1984
K-FLEX OSTOMY POUCH
K840266
Coloplast A/S
Gastroenterology & Urology
Cleared Jan 04, 1984
ASPIRATING HANDLE W/BACKFLUSHING CAPAB
K832560
Precision Medical Instruments, Inc.
Gastroenterology & Urology · 156d
Cleared Jan 03, 1984
THERAPEUTIC EXCHANGE SYSTEM
K831423 · LQQ
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 245d
Cleared Jan 03, 1984
PLASTIC LEG BAG
K831530 · KNX
Forever-Dry, Inc.
Gastroenterology & Urology · 236d
Cleared Jan 03, 1984
ULTRAFILTRATION CONTROLLER
K832547 · KDI
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 155d