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
3457–3480 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Oct 25, 2004
AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM
K042300 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 62d
Cleared Oct 25, 2004
URO PRO
K042457 · LJH
W.O.M. World of Medicine AG
Gastroenterology & Urology · 45d
Cleared Oct 22, 2004
RM3 RENAL PRESERVATION SYSTEM
K042224 · KDN
Waters Instruments, Inc.
Gastroenterology & Urology · 66d
Cleared Oct 20, 2004
MEGA PURE CART
K031832 · FIP
Mega Services
Gastroenterology & Urology · 495d
Cleared Oct 15, 2004
MODIFICATION TO URETERAL STENT
K040760 · FAD
Applied Medical Resources Corp.
Gastroenterology & Urology · 204d
Cleared Oct 12, 2004
TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
K042561 · LNS
Fmd, LLC
Gastroenterology & Urology · 21d
Cleared Oct 07, 2004
GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS
K041005 · KDI
Gambro Renal Products
Gastroenterology & Urology · 171d
Cleared Oct 07, 2004
ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
K041163 · FIP
Isopure, Corp.
Gastroenterology & Urology · 157d
Cleared Oct 06, 2004
VACUUM ASSISTED CORE BIOPSY DEVICE
K042290 · KNW
Suros Surgical Systems, Inc.
Gastroenterology & Urology · 43d
Cleared Oct 04, 2004
VARICES NEEDLE
K031238 · FBK
Scandimed. A.S.
Gastroenterology & Urology · 535d
Cleared Oct 01, 2004
XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587,...
K041962 · FGE
Abbott Laboratories
Gastroenterology & Urology · 72d
Cleared Oct 01, 2004
ZILVER 518 BILIARY STENT
K042518 · FGE
Cook, Inc.
Gastroenterology & Urology · 15d
Cleared Sep 30, 2004
WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM
K042065 · MQR
Boston Scientific Corp
Gastroenterology & Urology · 59d
Cleared Sep 30, 2004
V-CORE FULL CORE BREAST BIOPSY INSTRUMENT
K042464 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 17d
Cleared Sep 29, 2004
BARDEX I.C. LATEX FOLEY CATHETER
K040658 · MJC
C.R. Bard, Inc.
Gastroenterology & Urology · 201d
Cleared Sep 27, 2004
PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER
K041914 · MSD
Kendall
Gastroenterology & Urology · 73d
Cleared Sep 24, 2004
FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211
K041792 · KDJ
Fresenius Medical Care North America
Gastroenterology & Urology · 84d
Cleared Sep 23, 2004
DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER
K042016 · MSD
Datascope Corp.
Gastroenterology & Urology · 58d
Cleared Sep 21, 2004
CAVERMAP SURGICAL AID
K041732 · FGM
Blue Torch Medical Technologies
Gastroenterology & Urology · 88d
Cleared Sep 16, 2004
MEDCOMP T-3
K033570 · NIE
Medcomp
Gastroenterology & Urology · 309d
Cleared Sep 10, 2004
5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
K041791 · NQJ
Chf Solutions, Inc.
Gastroenterology & Urology · 70d
Cleared Sep 10, 2004
ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
K042225 · FAJ
Acmi Corporation
Gastroenterology & Urology · 24d
Cleared Sep 08, 2004
VACUUM ASSISTED CORE BIOPSY DEVICE
K034021 · KNW
Suros Surgical Systems, Inc.
Gastroenterology & Urology · 259d
Cleared Sep 08, 2004
SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM
K042136 · KNW
Sanarus Medical, Inc.
Gastroenterology & Urology · 30d