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
3769–3792 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Apr 10, 2003
VITALCARE URETHRAL CATHETER RED RUBBER
K023872 · EZD
Vitalcare, Inc.
Gastroenterology & Urology · 141d
Cleared Apr 07, 2003
PORTABLE RO+ MODEL MROS09
K030059 · FIP
Ameriwater
Gastroenterology & Urology · 90d
Cleared Apr 03, 2003
FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020
K022112 · KNT
Fortune Medical Instrument Corp.
Gastroenterology & Urology · 279d
Cleared Mar 31, 2003
JOSTENT SELFX, MODELS 015SX4406
K030053 · FGE
Jomed AG
Gastroenterology & Urology · 98d
Cleared Mar 25, 2003
BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
K030645 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 25d
Cleared Mar 24, 2003
LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT
K024301 · ODC
Lsi Solutions
Gastroenterology & Urology · 90d
Cleared Mar 24, 2003
XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT
K030194 · KNS
The Olympus Optical Co.
Gastroenterology & Urology · 62d
Cleared Mar 21, 2003
100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM
K030107 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 67d
Cleared Mar 20, 2003
FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS
K023162 · FIE
Fresenius Medical Care
Gastroenterology & Urology · 178d
Cleared Mar 19, 2003
OPTION-VF URINARY CATHETER, FV14218
K023090 · EZL
Opticon Medical, Inc.
Gastroenterology & Urology · 183d
Cleared Mar 17, 2003
BARD AQUAGUIDE URETERAL CONDUIT
K030438 · FED
C.R. Bard, Inc.
Gastroenterology & Urology · 34d
Cleared Mar 17, 2003
MODIFICATION TO CONTOUR POLARIS URETERAL STENT
K030503 · FAD
Boston Scientific Corp
Gastroenterology & Urology · 26d
Cleared Mar 14, 2003
SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT
K024124 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 88d
Cleared Mar 11, 2003
VACUFLASH BIOPSY SYSTEM
K024089 · KNW
Bip USA, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 10, 2003
LIFESTENT BILIARY ENDOPROSTHESIS
K023121 · FGE
Orbus Medical Technologies
Gastroenterology & Urology · 172d
Cleared Mar 10, 2003
IRRIGATION SETS
K023808 · LJH
International Medsurg Connection
Gastroenterology & Urology · 116d
Cleared Mar 10, 2003
SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM
K030409 · FGE
Cordis Corp.
Gastroenterology & Urology · 31d
Cleared Mar 10, 2003
AMERICAN CATHETER, MODEL W3
K030538 · EZD
Catheter, LLC
Gastroenterology & Urology · 18d
Cleared Mar 07, 2003
MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
K030460 · PAG
Brennen Medical, Inc.
Gastroenterology & Urology · 23d
Cleared Mar 05, 2003
FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
K022412 · KDJ
Fresenius Medical Care North America
Gastroenterology & Urology · 224d
Cleared Mar 04, 2003
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
K024015 · NLM
Alliance Medical Corp.
Gastroenterology & Urology · 90d
Cleared Feb 28, 2003
CATHETER CONNECTOR
K023690 · KNY
World Metals, Inc.
Gastroenterology & Urology · 119d
Cleared Feb 28, 2003
ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE
K023985 · KPO
Rockwell Medical Technologies, Inc.
Gastroenterology & Urology · 88d
Cleared Feb 27, 2003
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
K022980 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 171d