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
889–912 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Sep 14, 2021
End Cap
K210461 · MSD
Medical Components Inc (Medcomp)
Gastroenterology & Urology · 210d
Cleared Sep 10, 2021
JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve
K210625 · ODC
Fujifilm Medwork GmbH
Gastroenterology & Urology · 192d
Cleared Sep 09, 2021
Rocket Platinum Cured Cathter
K210509 · DWM
Rocket Medical Plc
Gastroenterology & Urology · 199d
Cleared Sep 08, 2021
Leva Pelvic Health System
K212495 · HIR
Renovia, Inc.
Gastroenterology & Urology · 30d
Cleared Sep 06, 2021
SANSIN Tubing Sets for Hemodialysis
K202796 · FJK
Jiangxi Sanxin Medtec Co., Ltd.
Gastroenterology & Urology · 348d
Cleared Sep 03, 2021
KARL STORZ Flexible HD Cysto-Urethroscope System
K212476 · FAJ
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 28d
Cleared Sep 03, 2021
BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing,...
K210342 · ODC
STERIS Corporation
Gastroenterology & Urology · 210d
Cleared Aug 27, 2021
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
K211684 · NEZ
Given Imaging Ltd. (Medtronic)
Gastroenterology & Urology · 87d
Cleared Aug 27, 2021
ENFit Reusable Enteral Syringe
K203613 · PNR
Shantou Wealy Medical Instrument Co.,Ltd
Gastroenterology & Urology · 260d
Cleared Aug 25, 2021
Instinct Plus Endoscopic Clipping Device
K212323 · PKL
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 30d
Cleared Aug 19, 2021
Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
K212296 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 28d
Cleared Aug 19, 2021
Enteral Extension Sets
K203633 · PIF
GBUK Group, Ltd.
Gastroenterology & Urology · 251d
Cleared Aug 19, 2021
Servator P SALF Solution with THAM
K202652 · KDN
S.A.L.F. Spa
Gastroenterology & Urology · 339d
Cleared Aug 18, 2021
EnteraLoc Flow
K210971 · PIF
Vonco Products
Gastroenterology & Urology · 140d
Cleared Aug 12, 2021
SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset
K210661 · KDI
Quanta Dialysis Technologies, Ltd.
Gastroenterology & Urology · 161d
Cleared Aug 04, 2021
PrevisEA Device
K211068 · DQD
Entac Medical, Inc.
Gastroenterology & Urology · 114d
Cleared Jul 30, 2021
Mini PCNL-System
K200770 · FED
Trokamed GmbH
Gastroenterology & Urology · 492d
Cleared Jul 29, 2021
OCS Lung Solution
K211314 · MSB
TransMedics, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 23, 2021
HMB32 Dialysis Solution
K212052 · KPO
Haemopharm Biofluids S.R.L.
Gastroenterology & Urology · 23d
Cleared Jul 23, 2021
GI Genius
K211951 · QNP
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology · 30d
Cleared Jul 23, 2021
HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)
K201160 · ESW
M.I. Tech Co., Ltd.
Gastroenterology & Urology · 449d
Cleared Jul 22, 2021
WiScope OM Endoscope System, WiScope Single-Use Digital Flexible...
K210579 · FGB
OTU Medical, Inc.
Gastroenterology & Urology · 146d
Cleared Jul 21, 2021
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
K211223 · OTN
Boston Scientific Corporation
Gastroenterology & Urology · 89d
Cleared Jul 08, 2021
END 200 Endoscopic Tubeset
K202922 · FCX
Palliare , Ltd.
Gastroenterology & Urology · 282d