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
3553–3576 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Apr 07, 2004
XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006,...
K040667 · FGE
Abbott Laboratories
Gastroenterology & Urology · 23d
Cleared Apr 06, 2004
COOK URETERAL BALLOON DILATION CATHETER SET
K040127 · EZN
Cook Urological, Inc.
Gastroenterology & Urology · 76d
Cleared Apr 05, 2004
CUSTODIOL
K032794 · MSB
Dr. Franz Kohler Chemie GmbH
Gastroenterology & Urology · 210d
Cleared Apr 01, 2004
NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL
K030784 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 386d
Cleared Apr 01, 2004
RABBIT
K040087 · KNW
Scion International, Inc.
Gastroenterology & Urology · 76d
Cleared Mar 30, 2004
BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM
K040027 · FGE
Boston Scientific
Gastroenterology & Urology · 82d
Cleared Mar 24, 2004
EASY LOOP, MODEL EZL-01
K040110 · EZP
Tools For Surgery, LLC
Gastroenterology & Urology · 64d
Cleared Mar 23, 2004
ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM
K033149 · KPL
Ultimate Concepts, Inc.
Gastroenterology & Urology · 175d
Cleared Mar 19, 2004
SOLAR GI SYSTEM
K031084 · FFX
Medical Measurement Systems B.V.
Gastroenterology & Urology · 350d
Cleared Mar 19, 2004
SHAPE LOCKING ENDOSCOPIC OVERTUBE
K033954 · FED
Usgi Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Mar 17, 2004
BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996
K040538 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 15d
Cleared Mar 16, 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER
K040492 · MSD
Boston Scientific Corp
Gastroenterology & Urology · 19d
Cleared Mar 16, 2004
ZILVER 635 BILIARY STENT
K040505 · FGE
Cook, Inc.
Gastroenterology & Urology · 18d
Cleared Mar 16, 2004
LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
K040550 · FGE
Orbus Medical Technologies
Gastroenterology & Urology · 14d
Cleared Mar 12, 2004
TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088
K040447 · LQC
Boston Scientific Corp
Gastroenterology & Urology · 21d
Cleared Mar 09, 2004
SOHNIKS
K033191 · FAJ
Sohniks Endoscopy, Inc.
Gastroenterology & Urology · 160d
Cleared Mar 05, 2004
COLONOSIGHT MODEL 510B
K032688 · FDF
Sightline Technologies , Ltd.
Gastroenterology & Urology · 189d
Cleared Mar 05, 2004
INTEGRAL HEMODIALYSIS CATHETER
K040260 · MSD
Arrow Int'L.
Gastroenterology & Urology · 30d
Cleared Mar 03, 2004
ATRION MEDICAL QL INFLATION DEVICE
K032840 · KOE
Atrion Medical Products, Inc.
Gastroenterology & Urology · 174d
Cleared Mar 03, 2004
B.BRAUN PREMIXED DIALYSATE
K034066 · KPO
B.Braun Medical, Inc.
Gastroenterology & Urology · 63d
Cleared Mar 03, 2004
PLUME SAFETY AVF NEEDLE
K040247 · FIE
Jms North America Corp.
Gastroenterology & Urology · 29d
Cleared Mar 01, 2004
TRAPMATIC SYSTEM SET
K033616 · KNW
H.S Hospital Service S.P.A
Gastroenterology & Urology · 105d
Cleared Feb 27, 2004
CONDUCTIVITY/TDS CALIBRATOR SOLUTION
K033330 · FKH
Mesa Laboratories, Inc.
Gastroenterology & Urology · 134d
Cleared Feb 27, 2004
TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING
K040129 · GCA
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 37d