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
6457–6480 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Oct 30, 1991
URS-HYDRO-DILATOR MODEL NUMBER 2164.00
K912331 · EZN
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 159d
Cleared Oct 25, 1991
DOBBHOFF(R) PERCUTANEOUS TRANSHEPAT BILIARY STENT
K913073 · FGE
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 106d
Cleared Oct 25, 1991
COX DISPOSABLE CYTOLOGY BRUSHES
K914466 · FDX
Cox Medical Ent., Inc.
Gastroenterology & Urology · 18d
Cleared Oct 23, 1991
SPOON FORCEPS, 11MM
K911364 · LQC
Northgate Technologies, Inc.
Gastroenterology & Urology · 209d
Cleared Oct 23, 1991
JTECH 50 SERIES CUTTING LOOP
K913587 · FJL
J-Tech, Inc.
Gastroenterology & Urology · 72d
Cleared Oct 11, 1991
MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS
K912344 · FAE
Dacomed Corp.
Gastroenterology & Urology · 136d
Cleared Oct 10, 1991
MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000
K912265 · FED
Medical Laser, Inc.
Gastroenterology & Urology · 141d
Cleared Oct 09, 1991
FST CATH-UD CATHETER, MODIFICATION
K913113 · FEN
Fiberoptic Sensor Technlogies, Inc.
Gastroenterology & Urology · 96d
Cleared Oct 08, 1991
MARLOW VERRES NEEDLES
K913586 · GCT
Marlo Surgical Technology
Gastroenterology & Urology · 57d
Cleared Oct 08, 1991
FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM
K913721 · FEN
Fiberoptic Sensor Technlogies, Inc.
Gastroenterology & Urology · 49d
Cleared Oct 08, 1991
2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH
K913841 · FGE
Endovations
Gastroenterology & Urology · 43d
Cleared Oct 07, 1991
ZIMMON ESOPHAGO-GASTRIC BALLOON TAMPONADE DEVICE
K900623 · KNT
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 606d
Cleared Oct 05, 1991
COX DISPOSABLE BIOPSY FORCEP
K913883 · FCL
Cox Medical Ent., Inc.
Gastroenterology & Urology · 37d
Cleared Oct 04, 1991
SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT
K913294 · GCA
Surgitek Medical Engineering Corp.
Gastroenterology & Urology · 72d
Cleared Oct 04, 1991
SILICONE MALE EXTERNAL CATHETER
K913524 · EXJ
Mentor Corp.
Gastroenterology & Urology · 57d
Cleared Sep 30, 1991
CYTOLOGY BRUSH
K913248 · FDX
Annex Medical, Inc.
Gastroenterology & Urology · 70d
Cleared Sep 30, 1991
FIBRETWINS
K913603 · KNT
Oral-B Laboratories
Gastroenterology & Urology · 47d
Cleared Sep 27, 1991
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER WITH BALLOON
K911630 · FGE
Baxter Healthcare Corp
Gastroenterology & Urology · 169d
Cleared Sep 27, 1991
MENTOR BLACK LIGHT INJECTION STENT SET
K912060 · FAD
Mentor Corp.
Gastroenterology & Urology · 141d
Cleared Sep 27, 1991
SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200
K912447 · FET
Medical Laser, Inc.
Gastroenterology & Urology · 116d
Cleared Sep 27, 1991
MINNILERT(R) PRESSURE MONITOR
K913483 · KOC
Minntech Corp.
Gastroenterology & Urology · 52d
Cleared Sep 25, 1991
LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE
K912839 · FBW
Baxter Healthcare Corp
Gastroenterology & Urology · 91d
Cleared Sep 23, 1991
CHOLANGIOGRAPHY CATHETER
K912122 · FGE
Wiltek Medical, Inc.
Gastroenterology & Urology · 132d
Cleared Sep 23, 1991
WILTEK STANDARD CHOLANGIOGRAPHY CATHETER
K912288 · FGE
Wiltek Medical, Inc.
Gastroenterology & Urology · 123d