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
1729–1752 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jul 12, 2016
Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/...
K161055 · KPI
Fuji Dynamics , Ltd.
Gastroenterology & Urology · 89d
Cleared Jul 12, 2016
RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set
K160077 · LJE
Jbw7 Innovations, LLC
Gastroenterology & Urology · 180d
Cleared Jul 11, 2016
PeriCoach OTC
K160758 · HIR
Analytica, Ltd.
Gastroenterology & Urology · 115d
Cleared Jun 30, 2016
Relizorb
K161247 · PLQ
Alcresta Therapeutics, Inc.
Gastroenterology & Urology · 58d
Cleared Jun 29, 2016
Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter...
K161186 · KGE
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 63d
Cleared Jun 27, 2016
EndoChoice Water Bottle Cap Irrigation System
K161482 · FEQ
Endochoice, Inc.
Gastroenterology & Urology · 27d
Cleared Jun 27, 2016
Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode
K151976 · FAS
Omnitech Systems, Inc.
Gastroenterology & Urology · 347d
Cleared Jun 24, 2016
Ultrathane Endoureterotomy Stent Set
K160891 · FAD
Cook Incorporated
Gastroenterology & Urology · 85d
Cleared Jun 21, 2016
Aquarius Stoma Measuring Device
K152246 · KNT
Degania Silicone , Ltd.
Gastroenterology & Urology · 316d
Cleared Jun 20, 2016
Lehman Manometry Catheter
K160170 · FFX
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 145d
Cleared Jun 17, 2016
Monoject
K161045 · PNR
Covidien
Gastroenterology & Urology · 65d
Cleared Jun 17, 2016
NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and...
K161039 · PNR
Neomed, Inc.
Gastroenterology & Urology · 65d
Cleared Jun 17, 2016
EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit...
K161003 · PIF
Boston Scientific Corporation
Gastroenterology & Urology · 67d
Cleared Jun 17, 2016
SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr...
K152771 · KNS
Sumitomo Bakelite Co., Ltd.
Gastroenterology & Urology · 266d
Cleared Jun 16, 2016
United Urologics Intermittent Catheter
K160795 · GBM
Robling Medical
Gastroenterology & Urology · 85d
Cleared Jun 14, 2016
Disposable Hot Biopsy Forceps
K160625 · KGE
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 102d
Cleared Jun 10, 2016
Pall-Aquasafe Water Filter
K153434 · NHV
Pall International Sarl
Gastroenterology & Urology · 196d
Cleared Jun 07, 2016
EndoCure Model EUR078A
K161147 · FBN
Endocure Technologies, Inc.
Gastroenterology & Urology · 46d
Not Cleared Jun 03, 2016
WallFlex Biliary RX Fully Covered Stent System RMV
DEN150040 · PNB
Boston Scientific
Gastroenterology & Urology · 280d
Cleared May 26, 2016
Seal Single-Use Biopsy Valve
K161167 · OCX
Endochoice, Inc.
Gastroenterology & Urology · 30d
Cleared May 20, 2016
United Urologics Closed System Catheter
K160877 · KOD
Robling Medical, Inc.
Gastroenterology & Urology · 51d
Cleared May 19, 2016
SmartStart Air/Water and Suction Valves
K160403 · ODC
Endochoice, Inc.
Gastroenterology & Urology · 97d
Cleared May 19, 2016
EasyPass Guidewire
K153264 · OCY
Medi-Globe Corporation
Gastroenterology & Urology · 189d
Cleared May 17, 2016
Third Eye Panoramic Auxiliary Endoscopy System - Resposable
K160356 · FDF
Avantis Medical Systems, Inc.
Gastroenterology & Urology · 99d