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
3937–3960 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared May 31, 2002
ENTERYX INJECTOR
K013712 · FBK
Enteric Medical Technologies
Gastroenterology & Urology · 204d
Cleared May 30, 2002
SURX RF SYSTEM
K020952 · MUK
Surx, Inc.
Gastroenterology & Urology · 66d
Cleared May 24, 2002
14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL
K020315 · MSD
Medcomp
Gastroenterology & Urology · 115d
Cleared May 24, 2002
IRRIGATING CANNULA
K020614 · OCX
Ca Guard, Ltd.
Gastroenterology & Urology · 88d
Cleared May 22, 2002
MEDCOMP ASH SPLIT-CATH II
K020465 · MSD
Medcomp
Gastroenterology & Urology · 99d
Cleared May 22, 2002
APPLIED URETERAL CATHETER
K020577 · EYB
Applied Medical Resources Corp.
Gastroenterology & Urology · 90d
Cleared May 22, 2002
HDM97
K020908 · FIZ
Ibp Instruments GmbH
Gastroenterology & Urology · 63d
Cleared May 22, 2002
HDM99
K020909 · FIZ
Ibp Instruments GmbH
Gastroenterology & Urology · 63d
Cleared May 20, 2002
BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE,...
K020867 · KNW
Worldwide Medical Technologies, LLC
Gastroenterology & Urology · 63d
Cleared May 17, 2002
24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED...
K021212 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 30d
Cleared May 15, 2002
HERNIAMESH T-SLING
K020652 · PAH
Herniamesh
Gastroenterology & Urology · 76d
Cleared May 15, 2002
MODIFICATION TO SPARC SLING SYSTEM
K021263 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 23d
Cleared May 09, 2002
MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING
K013053 · LKY
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 240d
Cleared May 09, 2002
DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)
K020430 · NFK
Diatek, Inc.
Gastroenterology & Urology · 90d
Cleared May 09, 2002
ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR
K021166 · FDC
Acmi-Circon Corporation
Gastroenterology & Urology · 28d
Cleared May 08, 2002
WILSON-COOK ZILVER BILIARY STENT
K020788 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 58d
Cleared May 07, 2002
MAINSTREAM WATER PURIFICATION DEVICE
K012716 · NHV
Prismedical Corp.
Gastroenterology & Urology · 265d
Cleared May 06, 2002
PPD BALLOON DILATATION CATHETER
K020379 · KNT
Telemed Systems, Inc.
Gastroenterology & Urology · 90d
Cleared May 03, 2002
INDWELLING FECAL MANAGEMENT SYSTEM
K012113 · KNT
Bowel Management Systems, LLC
Gastroenterology & Urology · 301d
Cleared May 02, 2002
GIVEN DIAGNOSTIC SYSTEM
K020341 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 90d
Cleared May 02, 2002
VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA
K021074 · FAJ
Olympus America, Inc.
Gastroenterology & Urology · 30d
Cleared Apr 29, 2002
REPROCESSED GUIDEWIRES
K012556 · NML
Sterilmed, Inc.
Gastroenterology & Urology · 264d
Cleared Apr 29, 2002
DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER
K013471 · LNS
E.S.W.L. Products, Inc.
Gastroenterology & Urology · 193d
Cleared Apr 26, 2002
SIIS#1 TISSUE SUSPENSION SYSTEM
K020705 · OTN
Tag Medical Products
Gastroenterology & Urology · 53d