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
121–144 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Dec 16, 2025
Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3,...
K251951 · FGB
Guangzhou Red Pine Medical Instrument...
Gastroenterology & Urology · 174d
Cleared Dec 16, 2025
PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family)
K251256 · FDS
Pentax of America, Inc.
Gastroenterology & Urology · 237d
Cleared Dec 12, 2025
Revi System
K252391 · QXM
Bluewind Medical , Ltd.
Gastroenterology & Urology · 134d
Cleared Dec 05, 2025
mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)
K252605 · FFX
Medspira, LLC
Gastroenterology & Urology · 109d
Cleared Dec 05, 2025
Gastric Alimetry
K252504 · MYE
Alimetry , Ltd.
Gastroenterology & Urology · 119d
Cleared Dec 05, 2025
Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr...
K251403 · FAS
Dornier Medtech America Inc (Dmta)
Gastroenterology & Urology · 213d
Cleared Dec 02, 2025
Disposable Endoscopic Injection Needles
K252021 · FBK
Changzhou New Med Micro-Medtech Co.,...
Gastroenterology & Urology · 155d
Cleared Nov 26, 2025
Vanquish Water Vapor Ablation Device
K252388 · KNS
Francis Medical, Inc.
Gastroenterology & Urology · 118d
Cleared Nov 25, 2025
Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
K252889 · KNS
Olympus Medical Systems Corporation
Gastroenterology & Urology · 76d
Cleared Nov 24, 2025
BCM2-Body Composition Monitor
K250634 · DSB
Fresenius Medical Care Renal...
Gastroenterology & Urology · 266d
Cleared Nov 19, 2025
Focal One®
K251910 · PLP
Edap Technomed, Inc.
Gastroenterology & Urology · 152d
Cleared Nov 18, 2025
Miniature Telescope for Urology (27033AA)
K253411 · FGB
Karl Storz SE & CO. KG
Gastroenterology & Urology · 49d
Cleared Nov 14, 2025
AquaC UNO H
K250471 · FIP
Fresenius Medical Care Renal...
Gastroenterology & Urology · 269d
Cleared Nov 12, 2025
Hemoclip
K252271 · PKL
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 114d
Cleared Oct 31, 2025
GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100
K251041 · FDS
Actuated Medical, Inc.
Gastroenterology & Urology · 211d
Cleared Oct 31, 2025
Flexible Ureterorenoscope system (Electronic Endoscope Image Processor,...
K250917 · FGB
Shenzhen Sanping Image Technology...
Gastroenterology & Urology · 218d
Cleared Oct 30, 2025
HANAROSTENT Esophagus Upper (CCC)
K253327 · ESW
M.I. Tech Co., Ltd.
Gastroenterology & Urology · 30d
Cleared Oct 30, 2025
Niti-S Esophageal Stent
K243619 · ESW
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 342d
Cleared Oct 24, 2025
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
K252646 · FCG
Olympus Medical Systems Corp.
Gastroenterology & Urology · 64d
Cleared Oct 23, 2025
UV5000W Handle
K253226 · FAJ
Uroviu Corporation
Gastroenterology & Urology · 24d
Cleared Oct 21, 2025
Disposable Balloon Catheter (B5-2Q)
K250409 · FGE
Olympus Medical Systems Corporation
Gastroenterology & Urology · 250d
Cleared Oct 17, 2025
X9 Ultrasound System
K251673 · SGH
X9, Inc.
Gastroenterology & Urology · 140d
Cleared Oct 17, 2025
Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series)
K250945 · KNS
Olympus Medical Systems Corp.
Gastroenterology & Urology · 203d
Cleared Oct 17, 2025
Biopsy Port Adapter
K250145 · ODC
Endosound, Inc.
Gastroenterology & Urology · 269d