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
1681–1704 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Dec 13, 2016
HPM-6000U
K162010 · KPI
BTL Industries, Inc.
Gastroenterology & Urology · 146d
Cleared Dec 13, 2016
Matrix Pre-Treatment Controller
K161844 · FIP
Better Water, LLC
Gastroenterology & Urology · 161d
Cleared Dec 09, 2016
Arc EndoCuff and Arc EndoCuff Vision
K162205 · FED
Boddingtons Plastics, Ltd.
Gastroenterology & Urology · 126d
Cleared Dec 06, 2016
DiLumen Endolumenal Interventional Platform
K162428 · FDF
Lumendi, LLC
Gastroenterology & Urology · 98d
Cleared Nov 30, 2016
TubeClear Control Box and Clearing Stem
K163092 · KNT
Actuated Medical, Inc.
Gastroenterology & Urology · 26d
Cleared Nov 29, 2016
Medline ENFit Syringe
K160642 · PIF
Medline Industries, Inc.
Gastroenterology & Urology · 267d
Cleared Nov 22, 2016
ConvertX Nephroureteral Stent System
K161277 · FAD
Brightwater Medical
Gastroenterology & Urology · 200d
Cleared Nov 22, 2016
U&U Enteral Syringe
K160855 · PNR
U&U Medical Technology Co, Ltd.
Gastroenterology & Urology · 239d
Cleared Nov 18, 2016
RAPIDO HOLLOW-FIBRE DIALYZERS
K160558 · KDI
Bellco Srl
Gastroenterology & Urology · 263d
Cleared Nov 15, 2016
Tablo Console
K160881 · KDI
Outset Medical, Inc.
Gastroenterology & Urology · 230d
Cleared Nov 14, 2016
Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
K162457 · PNG
Rocket Medical Plc
Gastroenterology & Urology · 73d
Cleared Nov 03, 2016
PleurX Peritoneal Catheter System
K160437 · PNG
Care Fusion
Gastroenterology & Urology · 260d
Cleared Oct 27, 2016
SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy...
K160316 · KNW
M.D.L. S.R.L.
Gastroenterology & Urology · 265d
Cleared Oct 21, 2016
CapsoCam Plus (SV-3) Capsule Endoscope System
K161773 · NEZ
CapsoVision, Inc.
Gastroenterology & Urology · 115d
Cleared Oct 21, 2016
NOSOGARD FILTERS
K153784 · NHV
Evoqua Water Technologies, LLC
Gastroenterology & Urology · 295d
Cleared Oct 20, 2016
Rockwell Medical CitraPure Acid Concetrate
K160847 · KPO
Rockwell Medical
Gastroenterology & Urology · 206d
Cleared Oct 18, 2016
Fujifilm Endoscope Models EC-600HL and EC-600LS
K162622 · FDF
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 28d
Cleared Oct 12, 2016
Express SD Biliary Monorail Premounted Stent System
K162404 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 44d
Cleared Oct 12, 2016
ClearPetra Suction-Evacuation Sheath
K161110 · FED
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 175d
Cleared Oct 12, 2016
FTRD System Set
K153550 · PKL
Ovesco Endoscopy AG
Gastroenterology & Urology · 306d
Cleared Sep 29, 2016
Nexcore GI Insufflator
K162332 · FCX
Nexcore Technology, LLC
Gastroenterology & Urology · 41d
Cleared Sep 29, 2016
SpeediCath Flex Coude
K161672 · GBM
Coloplast Corp.
Gastroenterology & Urology · 112d
Not Cleared Sep 26, 2016
Sensor Monitored Alimentary Restriction Therapy (SMART) Device
DEN150033 · ONY
Scientific Intake
Gastroenterology & Urology · 423d
Cleared Sep 22, 2016
Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with...
K162188 · PNR
Vr Medical Technology
Gastroenterology & Urology · 49d