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
73–96 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Mar 24, 2026
NanoKnife Generator (H78720300351US0)
K253198 · OAB
Angiodynamics
Gastroenterology & Urology · 179d
Cleared Mar 20, 2026
Percutaneous Endoscopic Gastrostomy (PEG) Kit
K254170 · PIF
Degania Silicone , Ltd.
Gastroenterology & Urology · 87d
Cleared Mar 19, 2026
ELISIO™-H
K260533 · KDI
Nipro Medical Corporation
Gastroenterology & Urology · 30d
Cleared Mar 19, 2026
Disposable Distal Cap
K253139 · FBN
Mirco-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 175d
Cleared Mar 17, 2026
GUARDIAN™ Quick Dip Residual Chlorine (5212)
K253863 · FKJ
Serim Research
Gastroenterology & Urology · 104d
Cleared Mar 13, 2026
BARE Wireguided Balloon Dilation Catheter (1235)
K253987 · FGE
GIE Medical
Gastroenterology & Urology · 91d
Cleared Mar 13, 2026
Niti-S SPAXUS Stent
K252648 · PCU
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 204d
Cleared Mar 12, 2026
Liv Pre-lubricated Intermittent Catheter
K260502 · EZD
HR Healthcare
Gastroenterology & Urology · 27d
Cleared Mar 12, 2026
Taurus Clip
K253734 · PKL
Taurus Endoscopy
Gastroenterology & Urology · 108d
Cleared Mar 12, 2026
Urocross Expander System (Model Numbers ES2018 and ES3025)
K253525 · QKA
Prodeon Medical, Inc.
Gastroenterology & Urology · 119d
Cleared Mar 12, 2026
Deep Capsule® (Deep Capsule US)
K250655 · QZF
Digestaid - Artificial Intelligence...
Gastroenterology & Urology · 372d
Cleared Mar 09, 2026
FUJIFILM Endoscope Model ED-S100TP
K251861 · FDT
Fujifilm Corporation
Gastroenterology & Urology · 265d
Cleared Mar 06, 2026
CVAC Image Processor
K260013 · FGB
Calyxo, Inc.
Gastroenterology & Urology · 60d
Cleared Mar 06, 2026
Single use stone retrieval balloons
K253132 · FGE
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 162d
Cleared Mar 06, 2026
Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR
K251807 · KGE
Olympus Medical Systems Corp.
Gastroenterology & Urology · 267d
Cleared Feb 23, 2026
Rubber Utility Catheter
K251864 · KOD
C.R. Bard, Inc.
Gastroenterology & Urology · 251d
Cleared Feb 22, 2026
Single Use Distal Cover MAJ-2315 (MAJ-2315)
K253646 · FDT
Olympus Medical Systems Corp.
Gastroenterology & Urology · 94d
Cleared Feb 21, 2026
Advanced Tissue Resection Device
K251692 · FDI
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 264d
Cleared Feb 20, 2026
Disposable Ureteral Stents
K251890 · FAD
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 245d
Cleared Feb 17, 2026
FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
K250550 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 357d
Cleared Feb 13, 2026
Endomina EZFuse system
K252400 · OCW
Endo Tools Therapeutics S.A.
Gastroenterology & Urology · 197d
Cleared Feb 12, 2026
Well-Life Incontinence Stimulation System (WL-2405i(P))
K251760 · KPI
Well-Life Healthcare , Ltd.
Gastroenterology & Urology · 248d
Cleared Feb 10, 2026
multiFlux 130 (F00013123)
K252459 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 189d
Cleared Feb 06, 2026
Hood DH-084STR
K253568 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 81d