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
1–24 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jul 31, 2026
EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
K261183 · ODG
Olympus Medical Systems Corporation
Gastroenterology & Urology · 112d
Cleared Jul 31, 2026
UniPearls® Embolic Microspheres
K252812 · KRD
Suzhou Haowei Medical Technology Co.,...
Gastroenterology & Urology · 330d
Cleared Jul 29, 2026
Stone Clear (BWSC-LP9-02)
K262200 · QNA
Sonomotion, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 28, 2026
ELISIO™-HX
K261399 · QAX
Nipro Medical Corporation
Gastroenterology & Urology · 90d
Cleared Jul 28, 2026
Revi System
K253651 · QXM
Bluewind Medical , Ltd.
Gastroenterology & Urology · 250d
Cleared Jul 27, 2026
ARCHIMEDES Biodegradable Stent (Medium)
K260835 · FGE
Q3 Medical USA, LLC (C/O Q3 Medical...
Gastroenterology & Urology · 136d
Cleared Jul 24, 2026
VS-370CF, VS-370CT
K262152 · FCX
VISION MEDICAL Co., Ltd.
Gastroenterology & Urology · 29d
Cleared Jul 24, 2026
Careflux H60
K261267 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 99d
Cleared Jul 24, 2026
SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium...
K261221 · GEX
Olympus Surgical Technologies America
Gastroenterology & Urology · 101d
Cleared Jul 24, 2026
PerfusiX-Imaging
K254180 · OWN
LIMIS Development B.V.
Gastroenterology & Urology · 213d
Cleared Jul 23, 2026
Perfadex Plus
K261644 · KDN
Xvivo Perfusion AB
Gastroenterology & Urology · 66d
Cleared Jul 20, 2026
BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C,...
K260516 · FGB
MacroLux Medical Technology Co., Ltd.
Gastroenterology & Urology · 153d
Cleared Jul 17, 2026
LoFric Origo Pro Coudé
K261658 · EZD
Wellspect AB
Gastroenterology & Urology · 59d
Cleared Jul 10, 2026
WallFlex Esophageal Stent System
K261978 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Jul 10, 2026
Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220)
K253514 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 246d
Cleared Jul 09, 2026
HYDROS Robotic System (HY1000)
K260723 · PZP
Procept Biorobotics
Gastroenterology & Urology · 126d
Cleared Jul 07, 2026
Luja Soft
K262045 · EZD
Coloplast A/S
Gastroenterology & Urology · 20d
Cleared Jul 02, 2026
FUJIFILM Processor EP-8000
K261880 · FET
Fujifilm Corporation
Gastroenterology & Urology · 27d
Cleared Jul 02, 2026
Insufflation Retention Device (IRD) (11173-325-101)
K261587 · FDF
Bpendo, LLC
Gastroenterology & Urology · 50d
Cleared Jul 01, 2026
Enteral Syringe (20ml, 60ml)
K252483 · PNR
Chirana T.Injecta,A.S.
Gastroenterology & Urology · 328d
Cleared Jun 24, 2026
Hydrophilic coated intermittent nalaton catheter for single use-ready to use...
K260394 · EZD
Hangzhou Jimushi Meditech Co., Ltd.
Gastroenterology & Urology · 138d
Cleared Jun 24, 2026
Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518...
K253393 · FGE
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 267d
Cleared Jun 23, 2026
AQUABEAM Robotic System
K253211 · PZP
Procept Biorobotics
Gastroenterology & Urology · 267d
Cleared Jun 22, 2026
Urocross Expander System (UES-2018-C1)
K261342 · QKA
Prodeon Medical, Inc.
Gastroenterology & Urology · 60d