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
265–288 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Apr 17, 2025
SimpleStitch Suturing System
K243750 · OCW
Envision Endoscopy
Gastroenterology & Urology · 133d
Cleared Apr 15, 2025
Percuflex Ureteral Stent
K250824 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Apr 11, 2025
Chlorine Sentinel II
K243898 · MSY
Nelson Environmental Technologies, Inc.
Gastroenterology & Urology · 113d
Cleared Apr 11, 2025
Flexible Ureterorenoscope (US27F-12-EU
K243857 · FGB
Shanghai AnQing Medical Instrument...
Gastroenterology & Urology · 116d
Cleared Apr 11, 2025
Disposable ureteral access sheath
K243710 · FED
Shenzhen Trious Medical Technology...
Gastroenterology & Urology · 130d
Cleared Apr 11, 2025
FUJIFILM Processor EP-8000
K243260 · FET
Fujifilm Corporation
Gastroenterology & Urology · 178d
Cleared Apr 10, 2025
XNY Disposable Gastric Calibration Tube
K250389 · KNT
Changzhou Xin Neng Yuan Medical...
Gastroenterology & Urology · 58d
Cleared Apr 04, 2025
Bicarby Dialysate RFP-402 (RFP-402-G)
K243786 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 116d
Cleared Apr 03, 2025
stay•safe® catheter extension set with Safe- Lock, 12 inch
K250404 · KDJ
Fresenius Medical Care Renal...
Gastroenterology & Urology · 50d
Cleared Mar 31, 2025
Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
K250663 · MUM
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 26d
Cleared Mar 31, 2025
Belzer UW® Cold Storage Solution (BTLBUW-001)
K243384 · KDN
Bridge TO Life
Gastroenterology & Urology · 151d
Cleared Mar 28, 2025
Flexi-Seal AIR (with ENFit Connector)
K243228 · KNT
Convatec
Gastroenterology & Urology · 171d
Cleared Mar 27, 2025
Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B,...
K243708 · FGB
Scivita Medical Technology Co., Ltd.
Gastroenterology & Urology · 115d
Cleared Mar 27, 2025
Levina Pelvic Floor Muscle Stimulator (RS-48)
K241862 · KPI
Zmi Electronics , Ltd.
Gastroenterology & Urology · 273d
Cleared Mar 26, 2025
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)
K243840 · KDN
Bridge TO Life
Gastroenterology & Urology · 103d
Cleared Mar 26, 2025
SB Knife Jr2 (MD-47702 and MD-47702L)
K241855 · KNS
Sb-Kawasumi Laboratories, Inc.
Gastroenterology & Urology · 272d
Cleared Mar 24, 2025
Glean Urodynamics System Male Delivery System (GUS-1000-M)
K243052 · EXQ
Bright Uro, Inc.
Gastroenterology & Urology · 178d
Cleared Mar 21, 2025
Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210)
K250517 · FED
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Mar 21, 2025
EHL Probe (SCDG-AS)
K243032 · FFK
Guangzhou Potent Medical Equipment...
Gastroenterology & Urology · 175d
Cleared Mar 21, 2025
Electrohydraulic Lithotriptor (TCS-B3-II)
K242888 · FFK
Guangzhou Potent Medical Equipment...
Gastroenterology & Urology · 179d
Cleared Mar 21, 2025
FX CorAL 40 (F00009214)
K242053 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 252d
Cleared Mar 20, 2025
Endoscopic Water Pump
K241704 · OCX
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 280d
Cleared Mar 19, 2025
Luer-Split MAJ-2092
K241842 · ODC
Olympus Medical Systems Corporation
Gastroenterology & Urology · 266d
Cleared Mar 18, 2025
Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
K243807 · LQR
Olympus Medical Systems Corp.
Gastroenterology & Urology · 97d