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
1489–1512 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Feb 09, 2018
Kohli Urinary Drainage Catheter
K172422 · EZL
Nellie Medical, LLC
Gastroenterology & Urology · 183d
Cleared Feb 08, 2018
NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm),...
K173805 · MSD
Marvao Medical Devices, Ltd.
Gastroenterology & Urology · 55d
Cleared Feb 07, 2018
PENTAX MEDICAL ED-3490TK, Video Duodenoscope
K161222 · FDT
Pentax Medical
Gastroenterology & Urology · 649d
Cleared Feb 05, 2018
Trans-anal Introducer
K171208 · FED
Visionsense, Ltd.
Gastroenterology & Urology · 286d
Cleared Feb 02, 2018
SpeediCath Flex Coude Pro
K180070 · GBM
Coloplast
Gastroenterology & Urology · 24d
Cleared Feb 01, 2018
Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip...
K171662 · KOD
Cook Incorporated
Gastroenterology & Urology · 241d
Cleared Jan 30, 2018
Uro-V Cystoscope
K171500 · FAJ
Uroviu Corporation
Gastroenterology & Urology · 252d
Cleared Jan 30, 2018
MiroCam Capsule Endoscope System
K170438 · NEZ
Intromedic Co., Ltd.
Gastroenterology & Urology · 351d
Cleared Jan 29, 2018
Rusch Intermittent Urethral Catheters
K173596 · EZC
Teleflex Medical
Gastroenterology & Urology · 69d
Cleared Jan 26, 2018
Mic-Key* SF Over-the-Wire Stoma Measuring Device
K173955 · KNT
Halyard Health, Inc.
Gastroenterology & Urology · 29d
Cleared Jan 24, 2018
Cycler Drain Bag Set
K173363 · KDJ
Fresenius Medical Care Renal...
Gastroenterology & Urology · 90d
Cleared Jan 19, 2018
Focus Cap
K171673 · FDF
Gce Medical Corporation
Gastroenterology & Urology · 227d
Cleared Jan 18, 2018
Barrx SB RFA Endoscopic Catheter
K173559 · KNS
Covidien, LLC
Gastroenterology & Urology · 62d
Cleared Jan 18, 2018
BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap
K172575 · FED
Baronova, Inc.
Gastroenterology & Urology · 143d
Cleared Jan 18, 2018
Pelvifine Pelvic Muscle Trainer
K163288 · KPI
Shenzhen Konmed Technology Co., Ltd.
Gastroenterology & Urology · 422d
Cleared Jan 11, 2018
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M
K171207 · ODG
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 261d
Cleared Jan 10, 2018
Swiss LithoClast Trilogy
K173234 · FEO
E.M.S Electro Medical Systems S.A
Gastroenterology & Urology · 97d
Cleared Jan 10, 2018
Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal...
K172929 · LJE
Boston Scientific Corporation
Gastroenterology & Urology · 107d
Cleared Jan 10, 2018
Instalief
K172358 · LKX
Privi Medical Pte, Ltd.
Gastroenterology & Urology · 160d
Cleared Jan 08, 2018
invendoscopy E210 System
K173085 · FDF
Invendo Medical GmbH
Gastroenterology & Urology · 101d
Cleared Jan 05, 2018
AquaShield System CO2- Fujifilm
K173650 · FEQ
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 38d
Cleared Jan 05, 2018
EON Portable Reverse Osmosis Water Purification System
K171099 · FIP
Cantel
Gastroenterology & Urology · 267d
Cleared Dec 29, 2017
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
K171573 · FDX
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 213d
Cleared Dec 28, 2017
UroLift System (UL400 and UL500)
K173087 · PEW
Neotract, Inc.
Gastroenterology & Urology · 90d