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
2785–2808 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jun 30, 2009
UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518
K091391 · FBK
Uroplasty, Inc.
Gastroenterology & Urology · 50d
Cleared Jun 29, 2009
NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER
K090885 · FIP
Nephros, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 29, 2009
HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L
K090980 · NWB
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 83d
Cleared Jun 26, 2009
ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165
K090583 · KGE
Apollo Endosurgery, Inc.
Gastroenterology & Urology · 114d
Cleared Jun 26, 2009
WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710,...
K091510 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 35d
Cleared Jun 25, 2009
ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285
K083685 · KNT
Mri Manufacturing and Research, Inc.
Gastroenterology & Urology · 195d
Cleared Jun 17, 2009
COSTORSOL
K091245 · KDN
Preservation Solutions, Inc.
Gastroenterology & Urology · 50d
Cleared Jun 11, 2009
FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES
K091490 · FER
Thd Spa
Gastroenterology & Urology · 22d
Cleared Jun 10, 2009
HABIB ENDOHPB
K083292 · KNS
Emcision , Ltd.
Gastroenterology & Urology · 212d
Cleared Jun 09, 2009
PRECISION ENDOSCOPIC INFRARED COAGULATOR
K083275 · KNS
Max Endoscopy, Inc.
Gastroenterology & Urology · 215d
Cleared Jun 09, 2009
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330,...
K091340 · FPD
Boston Scientific Corp
Gastroenterology & Urology · 34d
Cleared Jun 05, 2009
EXALIS, SOFTWARE VERSION 1.15
K083158 · KDI
Gambro, Inc.
Gastroenterology & Urology · 224d
Cleared Jun 04, 2009
REVOLUTION FULL CORE BIOPSY
K090611 · KNW
Inrad
Gastroenterology & Urology · 90d
Cleared Jun 02, 2009
BACKSTOP AND BACKSTOP INJECTOR
K090430 · ONJ
Pluromed, Inc.
Gastroenterology & Urology · 103d
Cleared May 29, 2009
EXTT-101
K082436 · HIR
Apimeds, Inc.
Gastroenterology & Urology · 277d
Cleared May 29, 2009
KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION
K083598 · ODA
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 175d
Cleared May 29, 2009
HEMORPEX SYSTEM
K090432 · FER
Angiologica B. M. Srl
Gastroenterology & Urology · 99d
Cleared May 28, 2009
PERCUCATH URINARY CATHETER
K090262 · EZL
Percuvision, LLC
Gastroenterology & Urology · 114d
Cleared May 28, 2009
DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS...
K090528 · MSD
C.R. Bard, Inc.
Gastroenterology & Urology · 90d
Cleared May 22, 2009
BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034
K082589 · FED
Barosense, Inc.
Gastroenterology & Urology · 256d
Cleared May 22, 2009
SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A,...
K091417 · OCY
Terumo Corp.
Gastroenterology & Urology · 9d
Cleared May 19, 2009
MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM
K091070 · FFX
Sierra Scientific Instruments, Inc.
Gastroenterology & Urology · 35d
Cleared May 18, 2009
VS-100 ILLUMINATION AND IMAGING SYSTEM
K090800 · FET
Schoelly Imaging, Inc.
Gastroenterology & Urology · 55d
Cleared May 15, 2009
BACKSTOP CATHETER, MODEL 60-0000-3100
K090270 · KOD
Pluromed, Inc.
Gastroenterology & Urology · 100d