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
721–744 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Oct 13, 2022
allFlex Ureteral Catheters, Krait Ureteral Catheters
K220730 · KOD
Allwin Medical Devices, Inc.
Gastroenterology & Urology · 213d
Cleared Oct 07, 2022
Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing
K221310 · OCX
Changzhou Endoclean Medical Device...
Gastroenterology & Urology · 155d
Cleared Oct 05, 2022
Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)
K222737 · FGB
Shanghai AnQing Medical Instrument...
Gastroenterology & Urology · 26d
Cleared Oct 03, 2022
Elastic Traction System
K222354 · QSW
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 60d
Cleared Sep 30, 2022
DoubleChek DC-1001
K212316 · KNT
Nasogastric Feeding Solutions, Ltd.
Gastroenterology & Urology · 431d
Cleared Sep 28, 2022
EndoGI S-Path Biliary Stent System
K222627 · FGE
Endo GI Medical
Gastroenterology & Urology · 28d
Cleared Sep 27, 2022
Clean Connecting Tube
K220785 · OCX
Yangzhou Fartley Medical Instrument...
Gastroenterology & Urology · 194d
Cleared Sep 26, 2022
Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video...
K222602 · FAJ
Zhuhai Pusen Medical Technology Co.,...
Gastroenterology & Urology · 28d
Cleared Sep 22, 2022
Disposable Polyp Snare
K220089 · FDI
Jiangsu Vedkang Medical Science and...
Gastroenterology & Urology · 254d
Cleared Sep 21, 2022
MCB UNIT Model: V10GMCBUS
K222542 · KNS
Lamidey Noury Medical
Gastroenterology & Urology · 30d
Cleared Sep 21, 2022
ArcSP Suprapubic Sling System
K222293 · OTN
Urocure, LLC
Gastroenterology & Urology · 51d
Cleared Sep 21, 2022
SpeediCath Flex Set
K222059 · EZD
Coloplast
Gastroenterology & Urology · 70d
Cleared Sep 16, 2022
Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket...
K222155 · PNR
Jiangsu Caina Medical Co.,Ltd
Gastroenterology & Urology · 58d
Cleared Sep 15, 2022
ArcTO Transobturator Sling System
K222468 · OTN
Urocure, LLC
Gastroenterology & Urology · 30d
Cleared Sep 14, 2022
Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip
K222503 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 27d
Cleared Sep 13, 2022
Female IC (Not Finalized)
K213575 · EZD
Hollister Incorporated
Gastroenterology & Urology · 307d
Cleared Sep 08, 2022
HD-550 Video Endoscope System
K222020 · NWB
Sonoscape Medical Corp.
Gastroenterology & Urology · 62d
Cleared Sep 08, 2022
Disposable Endoscope Valves System
K221331 · ODC
Changzhou Endoclean Medical Device...
Gastroenterology & Urology · 126d
Cleared Sep 07, 2022
AXIOS Stent and Electrocautery-Enhanced Delivery System
K220112 · PCU
Boston Scientific Corporation
Gastroenterology & Urology · 237d
Cleared Sep 06, 2022
TULSA-PRO System
K211858 · PLP
Profound Medical, Inc.
Gastroenterology & Urology · 447d
Cleared Aug 29, 2022
Rusch Intermittent Urethral Catheters
K222279 · EZC
Teleflex Medical
Gastroenterology & Urology · 31d
Cleared Aug 26, 2022
Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope...
K220159 · FGB
Shanghai AnQing Medical Instrument...
Gastroenterology & Urology · 219d
Not Cleared Aug 26, 2022
Vibrant System
DEN210052 · QTN
Vibrant, Ltd.
Gastroenterology & Urology · 269d
Cleared Aug 19, 2022
OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33),...
K221824 · OCX
Cipher Surgical Limited
Gastroenterology & Urology · 57d