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
985–1008 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Dec 15, 2020
Prefilled Syringe
K202698 · EZL
Hangzhou Primecare Medical Co., Ltd.
Gastroenterology & Urology · 90d
Cleared Dec 15, 2020
X-Tack Endoscopic HeliX Tacking System
K201808 · PKL
Apollo Endosurgery, Inc.
Gastroenterology & Urology · 167d
Cleared Dec 10, 2020
AquaPulse Irrigation Tubing
K202560 · OCX
Ga Health Company Limited
Gastroenterology & Urology · 97d
Cleared Dec 09, 2020
Cystoject Syringe Lever
K203321 · QBL
Urogen Pharma, Ltd.
Gastroenterology & Urology · 27d
Cleared Dec 09, 2020
ClearPetra Suction-Evacuation Sheath
K203119 · FED
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 54d
Cleared Dec 04, 2020
TubeClear System
K200646 · KNT
Actuated Medical, Inc.
Gastroenterology & Urology · 267d
Cleared Dec 03, 2020
ORISE ProKnife
K200404 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 288d
Cleared Nov 25, 2020
Nipro Dry Complete Dry Acid Concentrate for Hemodialysis
K193155 · KPO
Nipro Renal Solutions USA, Corp.
Gastroenterology & Urology · 377d
Not Cleared Nov 25, 2020
Parallel
DEN200029 · QMY
Mahana Therapeutics, Inc.
Gastroenterology & Urology · 209d
Cleared Nov 20, 2020
Dornier MAGELLAN Ureteral Access Sheath
K201815 · FED
Dornier Medtech America, Inc.
Gastroenterology & Urology · 142d
Cleared Nov 19, 2020
Homechoice Claria APD System, Sharesource Connectivity Platform for Use with...
K201867 · FKX
Baxter Healthcare Corporation
Gastroenterology & Urology · 135d
Cleared Nov 18, 2020
GlidePath 7.5F Long-Term Dialysis Catheter
K202150 · MSD
C.R. Bard, Inc.
Gastroenterology & Urology · 107d
Cleared Nov 13, 2020
SpeediCath Compact Set
K200820 · GBM
Coloplast
Gastroenterology & Urology · 228d
Cleared Nov 06, 2020
BioShield biopsy valve EUS - Linear
K202583 · ODD
STERIS Corporation
Gastroenterology & Urology · 59d
Cleared Nov 05, 2020
Gabriel 3 Way EnFit Valve
K201741 · PIF
Syncro Medical Innovations, Inc.
Gastroenterology & Urology · 133d
Cleared Nov 03, 2020
Blue Beacon Submucosal Injectable Solution
K200071 · PLL
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 295d
Cleared Nov 02, 2020
SpeediCath Compact Set
K192904 · GBM
Coloplast
Gastroenterology & Urology · 384d
Cleared Oct 30, 2020
FUJIFILM Distal End Cap
K203028 · FDT
Fujifilm Corporation
Gastroenterology & Urology · 28d
Cleared Oct 29, 2020
Flexible Video Cysto-Urethroscope (C-view)
K202957 · FAJ
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 29d
Cleared Oct 29, 2020
Nutriglide(TM) Nasal Feeding Tube
K202539 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 57d
Cleared Oct 29, 2020
Nelson Sentinel Series Basic Chlorine Sentinel
K193169 · MSY
Nelson Environmental Technologies, Inc.
Gastroenterology & Urology · 349d
Cleared Oct 26, 2020
G-EYE System
K202469 · FDF
Smart Medical Systems , Ltd.
Gastroenterology & Urology · 60d
Cleared Oct 21, 2020
PleurX Peritoneal Catheter System
K201155 · PNG
Care Fusion
Gastroenterology & Urology · 174d
Cleared Oct 19, 2020
Single Use Rotatable and Repositionable Hemoclip
K201771 · PKL
Anrei Medical (Hangzhou) Co., Ltd.
Gastroenterology & Urology · 112d