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
1969–1992 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Dec 17, 2014
The OnControl Bone Marrow Biopsy System by Vidacare
K142377 · KNW
Vidacare, LLC
Gastroenterology & Urology · 113d
Cleared Dec 17, 2014
GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM
K140284 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 316d
Cleared Dec 15, 2014
Intact Advance and Intact Excision XL, Intact BLES
K142477 · KNW
Intact Medical Corporation
Gastroenterology & Urology · 103d
Cleared Dec 15, 2014
WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER
K140667 · EZL
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 272d
Cleared Dec 10, 2014
AMERIWATER OZONE DISINFECTION SYSTEM
K141213 · FIN
Ameriwater
Gastroenterology & Urology · 212d
Cleared Dec 01, 2014
Resolution Clip
K142973 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 48d
Cleared Dec 01, 2014
AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V,...
K142285 · FIP
Ameriwater
Gastroenterology & Urology · 105d
Cleared Nov 26, 2014
RESOLVE BILIARY LOCKING DRAINAGE CATHETER
K141408 · FGE
Merit Medical Systems, Inc.
Gastroenterology & Urology · 182d
Cleared Nov 26, 2014
APEX
K141158 · KPI
Incontrol Medical, LLC
Gastroenterology & Urology · 205d
Cleared Nov 26, 2014
SYMETREX LONG TERM HEMODIALYSIS CATHETER
K140884 · MSD
Phase One Medical
Gastroenterology & Urology · 233d
Cleared Nov 25, 2014
Sherpa Pak Cardiac Transport System
K143074 · MSB
Paragonix Technologies, Inc.
Gastroenterology & Urology · 29d
Cleared Nov 25, 2014
Sherpa Pak Kidney Transport System
K143054 · KDN
Paragonix Technologies, Inc.
Gastroenterology & Urology · 33d
Cleared Nov 20, 2014
FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS
K142012 · PIF
Corpak Medsystems
Gastroenterology & Urology · 119d
Cleared Nov 19, 2014
ENDO-MARYLAND DISSECTOR
K141794 · KGE
Ovesco Endoscopy AG
Gastroenterology & Urology · 140d
Cleared Nov 18, 2014
TRACTION POLYPECTOMY SNARE
K140923 · FDI
Ovesco Endoscopy AG
Gastroenterology & Urology · 222d
Cleared Nov 18, 2014
UNIVERSA PERCULTANEOUS DRAINAGE CATHETER
K140085 · FEW
Cook Incorporated
Gastroenterology & Urology · 309d
Cleared Nov 17, 2014
THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM
K140595 · FDF
Avantis Medical Systems, Inc.
Gastroenterology & Urology · 255d
Cleared Nov 13, 2014
Shock Pulse-SE Lithotripsy System CYBERWAND II
K142428 · FEO
Cybersonics, Inc.
Gastroenterology & Urology · 76d
Cleared Nov 13, 2014
NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE
K140492 · MSD
Marvao Medical Devices, Ltd.
Gastroenterology & Urology · 259d
Cleared Nov 05, 2014
Acrobat Calibrated Tip Wire Guide
K142950 · OCY
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 26d
Cleared Oct 31, 2014
Bard RiteCath Intermittent Urinary Catheter
K142575 · EZD
C.R. Bard, Inc.
Gastroenterology & Urology · 49d
Cleared Oct 28, 2014
Well Lead PVC Urethral Catheter
K142563 · EZD
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 47d
Cleared Oct 27, 2014
Uroflowmeter
K142425 · EXY
Be Technologies, Inc.
Gastroenterology & Urology · 59d
Cleared Oct 24, 2014
NEPHROS DSU-H, NEPHROS SSU-H
K141731 · NHV
Nephros, Inc.
Gastroenterology & Urology · 119d