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
3025–3048 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Sep 14, 2007
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
K063259 · NEZ
Olympus Medical Systems Corporation
Gastroenterology & Urology · 319d
Cleared Sep 14, 2007
MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM
K063481 · FGE
Abbott Vascular, Inc.
Gastroenterology & Urology · 301d
Cleared Sep 14, 2007
EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND...
K071651 · ODE
Endogastric Solutions, Inc.
Gastroenterology & Urology · 88d
Cleared Sep 13, 2007
USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE
K072405 · FED
Usgi Medical
Gastroenterology & Urology · 17d
Cleared Sep 13, 2007
CURE CATHETER
K072539 · EZD
Cure Medical, LLC
Gastroenterology & Urology · 3d
Cleared Sep 07, 2007
NES REPROCESSED ENDOSCOPIC TROCAR
K060676 · NLM
Northeast Scientific, Inc.
Gastroenterology & Urology · 542d
Cleared Sep 07, 2007
NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE
K071145 · MPB
Nipro Medical Corporation
Gastroenterology & Urology · 136d
Cleared Sep 07, 2007
AQUADEX FLEXFLOW SYSTEM
K071854 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 64d
Cleared Sep 07, 2007
GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL
K072232 · KDI
Gambro Renal Products, Inc.
Gastroenterology & Urology · 28d
Cleared Aug 31, 2007
FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560
K071167 · FJS
Medigroup, Inc.
Gastroenterology & Urology · 127d
Cleared Aug 30, 2007
STORZ SLX-F2 STORM TOUCH
K070579 · LNS
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 182d
Cleared Aug 24, 2007
NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500
K071263 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 109d
Cleared Aug 24, 2007
AMS MINIARC SLING SYSTEM
K071902 · PAH
American Medical Systems, Inc.
Gastroenterology & Urology · 45d
Cleared Aug 22, 2007
15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET
K071422 · MSD
Rex Medical
Gastroenterology & Urology · 92d
Cleared Aug 20, 2007
CONMED LINVATEC 300W XENON LIGHT SOURCE
K070376 · GCT
Conmed Linvatec
Gastroenterology & Urology · 193d
Cleared Aug 20, 2007
URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12
K071822 · NAM
Uroplasty, Inc.
Gastroenterology & Urology · 48d
Cleared Aug 17, 2007
DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS
K071518 · KDI
B. Braun Medizintechnologie GmbH
Gastroenterology & Urology · 74d
Cleared Aug 15, 2007
ICATH, STERILESURE
K071496 · NWO
Colorado Catheter Company, Inc.
Gastroenterology & Urology · 76d
Cleared Aug 14, 2007
NEOGUIDE ENDOSCOPY SYSTEM
K070622 · FDF
Neoguide Systems, Inc.
Gastroenterology & Urology · 161d
Cleared Aug 13, 2007
MODIFICATION TO SOLAR GI
K071094 · FFX
Medical Measurement Systems B.V.
Gastroenterology & Urology · 117d
Cleared Aug 10, 2007
SELF-LIGHT DISPOSABLE ANOSCOPE
K070913 · FER
Sapimed S.P.A.
Gastroenterology & Urology · 130d
Cleared Aug 09, 2007
BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS...
K071884 · MNW
Jawon Medical Co., Ltd.
Gastroenterology & Urology · 31d
Cleared Aug 08, 2007
HF JUNIOR HEMOFILTER
K071298 · KDI
Minntech Corp.
Gastroenterology & Urology · 91d
Cleared Aug 02, 2007
BC (BODY COMPOSITION SOFTWARE)
K070999 · MNW
Rjl Systems, Inc.
Gastroenterology & Urology · 115d