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
3985–4008 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Mar 08, 2002
MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM
K013677 · FIP
Usfilter/Ionpure, Inc.
Gastroenterology & Urology · 121d
Cleared Mar 05, 2002
INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE
K013653 · HIR
Hollister, Inc.
Gastroenterology & Urology · 119d
Cleared Mar 04, 2002
LIFEMATE MLA MULTI-LINE ADAPTOR
K011269 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 312d
Cleared Mar 04, 2002
ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890
K014002 · KOB
Fortune Medical Instrument Corp.
Gastroenterology & Urology · 90d
Cleared Mar 01, 2002
MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON
K013737 · FGE
Telemed Systems, Inc.
Gastroenterology & Urology · 108d
Cleared Feb 28, 2002
SANDHILL SCIENTIFIC PEDIATEC PH PROBE
K013951 · FFT
Sandhill Scientific, Inc.
Gastroenterology & Urology · 90d
Cleared Feb 26, 2002
RUSCH MILLER-ABBOTT TUBE
K010797 · KNT
Rusch Intl.
Gastroenterology & Urology · 347d
Cleared Feb 26, 2002
RUSCH CANTOR TUBE
K010798 · KNT
Rusch Intl.
Gastroenterology & Urology · 347d
Cleared Feb 20, 2002
DFINER UROLOGICAL CATHETER
K013360 · FGI
Neoseed Technology,Llc
Gastroenterology & Urology · 133d
Cleared Feb 19, 2002
PROTOCO2L INSUFFLATOR MODEL 6400
K013219 · FCX
E-Z-Em, Inc.
Gastroenterology & Urology · 146d
Cleared Feb 15, 2002
ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY
K013276 · EZL
Sewoon Medical Co., Ltd.
Gastroenterology & Urology · 137d
Cleared Feb 14, 2002
REPROCESSED STONE RETRIEVAL BASKETS
K012581 · FFL
Sterilmed, Inc.
Gastroenterology & Urology · 189d
Cleared Feb 14, 2002
REPROCESSED ENDOSCOPIC ELECTRODES
K012685 · NLW
Sterilmed, Inc.
Gastroenterology & Urology · 184d
Cleared Feb 12, 2002
MODIFICATION TO VISTA STEREOSCOPE SYSTEM
K020301 · FET
Vista Medical Technologies, Inc.
Gastroenterology & Urology · 14d
Cleared Feb 11, 2002
STONELITH, MODEL V5
K011106 · LNS
Pck Electronic Industry and Trade Co,...
Gastroenterology & Urology · 306d
Cleared Feb 11, 2002
SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K020052 · FGE
Cordis Corp.
Gastroenterology & Urology · 34d
Cleared Feb 08, 2002
MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER
K012562 · MSD
Medical Components, Inc.
Gastroenterology & Urology · 184d
Cleared Feb 07, 2002
ENDOSCOPIC MULTI-FIRE CLIP APPLIER
K013889 · PKL
Inscope, LLC
Gastroenterology & Urology · 76d
Cleared Feb 06, 2002
GENTLE COLONICS IRRIGATION SYSTEM
K002102 · KPL
Gentle Colonics, Inc.
Gastroenterology & Urology · 574d
Cleared Feb 06, 2002
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
K014169 · FIP
Bob J. Johnson & Assoc., Inc.
Gastroenterology & Urology · 49d
Cleared Feb 05, 2002
TRAPSYSTEM SET
K013692 · KNW
H.S. Hospital Service S.R.L.
Gastroenterology & Urology · 90d
Cleared Feb 05, 2002
ERECAID CLASSIC SYSTEM
K020082 · LKY
Endocare, Inc.
Gastroenterology & Urology · 26d
Cleared Feb 04, 2002
MEDIGROUP CATHETER EXTENDER/REPAIR KIT
K012502 · FJS
Janin Group, Inc.
Gastroenterology & Urology · 185d
Cleared Feb 04, 2002
NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100
K013655 · KPO
Nxstage Medical, Inc.
Gastroenterology & Urology · 90d