FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Gastroenterology & Urology ×
9,917 results
25–48 of 9,917
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Sep 03, 2026
Rezum System
K262460 · KNS
Boston Scientific
Gastroenterology & Urology · 48d
Cleared Sep 03, 2026
Triton 1 System
K260503 · FDF
Neptune Medical, Inc.
Gastroenterology & Urology · 198d
Cleared Sep 01, 2026
UNIDRIVE Select System
K260884 · GCJ
Karl Storz SE & CO. KG
Gastroenterology & Urology · 168d
Cleared Aug 27, 2026
Disposable Distal Attachment D-201-13404
K260856 · FDS
Olympus Medical Systems Corporation
Gastroenterology & Urology · 164d
Cleared Aug 27, 2026
Gastrointestinal Videoscope Olympus GIF-2T1500
K260824 · FDS
Olympus Medical Systems Corporation
Gastroenterology & Urology · 167d
Cleared Aug 26, 2026
LithoVue Elite Digital Flexible Ureteroscope System
K261153 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 140d
Cleared Aug 26, 2026
Edi Catheter ENFit 6Fr/48 cm (6893166)
K253715 · PIF
Maquet Critical Care AB
Gastroenterology & Urology · 275d
Cleared Aug 21, 2026
Solo Scope Colonoscope System
K261015 · FDF
Gi View , Ltd.
Gastroenterology & Urology · 147d
Not Cleared Aug 20, 2026
Qoramatic Automated Stool Management
DEN250043 · SJB
Cm Technologies, Inc.
Gastroenterology & Urology · 339d
Cleared Aug 19, 2026
Nipro Dry Acid Concentrate Mixer
K260799 · KPO
Nipro Technical Solutions, Incoporated
Gastroenterology & Urology · 161d
Cleared Aug 17, 2026
MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)
K260224 · DSB
ImpediMed Limited
Gastroenterology & Urology · 203d
Cleared Aug 14, 2026
Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)
K262552 · FGB
Scivita Medical Technology Co., Ltd.
Gastroenterology & Urology · 21d
Cleared Aug 14, 2026
52Fr ViSiGi LUX™
K261890 · KNT
Boehringer Laboratories, LLC
Gastroenterology & Urology · 70d
Cleared Aug 10, 2026
Hemoclip (511 series, 543 series)
K254069 · PKL
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 235d
Cleared Aug 07, 2026
EW10-EC02 Endoscopy Support Program
K260567 · QNP
Fujifilm Corporation
Gastroenterology & Urology · 169d
Cleared Aug 07, 2026
Intuitive Endoluminal Gastrointestinal System (IG1000)
K253702 · FDS
Intuitive Surgical, Inc.
Gastroenterology & Urology · 256d
Cleared Aug 06, 2026
Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM)
K253469 · FIE
Mozarc Medical Us, LLC
Gastroenterology & Urology · 300d
Cleared Aug 05, 2026
Rusch Latex Gold Foley Catheter
K262056 · EZL
Teleflex Medical Sdn. Bhd.
Gastroenterology & Urology · 48d
Cleared Aug 05, 2026
Transurethral Catheter Safety Valve (TUCSV) (80050)
K260919 · KNY
Class Medical , Ltd.
Gastroenterology & Urology · 139d
Cleared Aug 05, 2026
Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16)
K260737 · EZD
Convatec
Gastroenterology & Urology · 152d
Cleared Aug 05, 2026
CAD - Lower GI (EC07-01)
K252853 · QNP
Xiamen Inno Medical Technology Co., Ltd.
Gastroenterology & Urology · 331d
Cleared Aug 04, 2026
Navigator™ Flex Ureteral Access Sheath Set
K261915 · FED
Boston Scientific Corporation
Gastroenterology & Urology · 56d
Cleared Aug 03, 2026
PuraStat-RM
K261504 · PHN
3-D Matrix, Inc.
Gastroenterology & Urology · 89d
Cleared Jul 31, 2026
EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
K261183 · ODG
Olympus Medical Systems Corporation
Gastroenterology & Urology · 112d