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
1921–1944 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Apr 01, 2015
CRIT-LINE IV SYSTEM
K141997 · KOC
Fresenius Medical Care
Gastroenterology & Urology · 252d
Cleared Mar 31, 2015
NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite...
K143567 · MSD
Marvao Medical Devices, Ltd.
Gastroenterology & Urology · 105d
Cleared Mar 31, 2015
SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)
K141991 · KNS
Olympus Medical Systems Copr.
Gastroenterology & Urology · 252d
Cleared Mar 27, 2015
Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter
K143609 · FGE
Olympus Surgical Technologies America
Gastroenterology & Urology · 98d
Cleared Mar 23, 2015
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD...
K141938 · LKN
Terumobct, Inc.
Gastroenterology & Urology · 249d
Cleared Mar 20, 2015
NxStage Therapeutic Plasma Exchange (TPE) Cartridge
K143313 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 121d
Cleared Mar 20, 2015
LM-9300 ELMA Lithotripter
K142561 · LNS
Lite-Med, Inc.
Gastroenterology & Urology · 190d
Not Cleared Mar 20, 2015
PROLONG
DEN130047 · PIA
Ergon Medical , Ltd.
Gastroenterology & Urology · 487d
Cleared Mar 19, 2015
Imbibe Aspirating XIA Taps
K143546 · KNW
Stryker Corporation
Gastroenterology & Urology · 94d
Cleared Mar 18, 2015
PeriCoach
K143580 · HIR
Analytica, Ltd.
Gastroenterology & Urology · 90d
Cleared Mar 17, 2015
MiroCam Capsule Endoscope System
K143663 · NEZ
Intromedic Co., Ltd.
Gastroenterology & Urology · 84d
Cleared Mar 16, 2015
NovaGold High Performance Guidewire
K150225 · OCY
Neometrics, Inc.
Gastroenterology & Urology · 42d
Cleared Mar 16, 2015
InTone
K150180 · KPI
Incontrol Medical, LLC
Gastroenterology & Urology · 48d
Cleared Mar 16, 2015
ARTEMIS LIGHT ENGINE
K141164 · NTN
Quest Medical Imaging
Gastroenterology & Urology · 315d
Cleared Mar 10, 2015
BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON
K142068 · OCX
Medovations, Inc.
Gastroenterology & Urology · 223d
Cleared Mar 04, 2015
EsophyX® Z Fastener Delivery Device
K143645 · ODE
Endogastric Solutions, Inc.
Gastroenterology & Urology · 72d
Cleared Feb 27, 2015
Single Use Biliary Balloon Dilator
K143303 · FGE
Olympus Medical Systems Corp.
Gastroenterology & Urology · 101d
Cleared Feb 25, 2015
GastriSail Gastric Positioning System
K143088 · KNT
Covidien
Gastroenterology & Urology · 120d
Cleared Feb 23, 2015
KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR
K142128 · PNR
Covidien
Gastroenterology & Urology · 203d
Cleared Feb 18, 2015
BODY COMPOSITION ANALYZER
K140045 · MNW
Jawon Medical Co., Ltd.
Gastroenterology & Urology · 406d
Not Cleared Feb 12, 2015
ECLIPSE SYSTEM
DEN140020 · PJH
Pelvalon
Gastroenterology & Urology · 233d
Cleared Feb 08, 2015
ENDOCAPSULE SOFTWARE 10
K142680 · NEZ
Olympus Medical Systems Corp.
Gastroenterology & Urology · 142d
Cleared Feb 03, 2015
ThinkMed Intermittent Catheter with/without Hydrophilic Coating
K142767 · GBM
Thinkmed Medical Technology Co., Ltd.
Gastroenterology & Urology · 131d
Cleared Jan 29, 2015
Mini ONE Enteral Extension Set
K142989 · PIF
Applied Medical Technology, Inc.
Gastroenterology & Urology · 105d