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
649–672 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Mar 29, 2023
PUMA-G System
K223916 · KGC
Coaptech, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 29, 2023
EndoDrill® Model X
K212423 · FCG
Bibbinstruments AB
Gastroenterology & Urology · 602d
Cleared Mar 28, 2023
Disposable Endoscopic Hemoclip
K222146 · PKL
Jiangsu Vedkang Medical Science and...
Gastroenterology & Urology · 251d
Cleared Mar 24, 2023
EVA5 Insufflator
K230474 · FCX
Palliare , Ltd.
Gastroenterology & Urology · 30d
Cleared Mar 24, 2023
Entarik Feeding Tube System
K230206 · KNT
Gravitas Medical, Inc.
Gastroenterology & Urology · 58d
Cleared Mar 17, 2023
Alio
K223073 · DRG
Alio, Inc.
Gastroenterology & Urology · 168d
Cleared Mar 17, 2023
KARL STORZ Bipolar Resectoscopes with HF Cable
K221893 · FJL
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 261d
Cleared Mar 09, 2023
MultiStage Balloon Dilatation Catheter
K222663 · FGE
Dongguan TT Medical, Inc.
Gastroenterology & Urology · 188d
Cleared Mar 06, 2023
Single-Use Video Flexible Ureterorenoscope System
K221158 · FGB
Guangzhou Red Pine Medical Instrument...
Gastroenterology & Urology · 319d
Cleared Mar 03, 2023
Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)
K222880 · KNT
Endolumik, Inc.
Gastroenterology & Urology · 162d
Cleared Mar 03, 2023
Polypectomy Snare
K221713 · FDI
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 263d
Cleared Mar 03, 2023
NIKKICART
K221652 · KPO
Renal Care Dialysis Solutions, S.A....
Gastroenterology & Urology · 269d
Cleared Mar 01, 2023
Endo SmartCap
K223040 · FAJ
Medivators, Inc.
Gastroenterology & Urology · 153d
Cleared Feb 27, 2023
Saneso Lens Wash Bottle Assembly (SAN-LWB-A)
K222173 · OCX
Saneso, Inc.
Gastroenterology & Urology · 221d
Cleared Feb 24, 2023
EsoCheck Cell Collection Device
K230339 · EOX
Lucid Diagnostics, Inc.
Gastroenterology & Urology · 17d
Cleared Feb 24, 2023
Veloxion System
K230205 · FJL
Corinth Medtech, Inc.
Gastroenterology & Urology · 30d
Cleared Feb 24, 2023
ELITONE Urge Urinary Incontinence Device
K223884 · QAJ
Elidah, Inc.
Gastroenterology & Urology · 59d
Not Cleared Feb 24, 2023
Pill Sense System
DEN220065 · QUD
Enterasense , Ltd.
Gastroenterology & Urology · 148d
Cleared Feb 22, 2023
Delta III Pro
K221903 · LNS
Dornier Medtech America, Inc.
Gastroenterology & Urology · 237d
Cleared Feb 17, 2023
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN...
K223466 · FGB
STERIS Corporation
Gastroenterology & Urology · 92d
Cleared Feb 16, 2023
Single-use Video Pancreaticobiliary Scope, PB Digital Controller
K221784 · FBN
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 240d
Cleared Feb 15, 2023
ReShape Calibration Tubes
K230131 · KNT
Reshape Lifesciences
Gastroenterology & Urology · 29d
Cleared Feb 15, 2023
Altis Single Incision Sling System
K221874 · PAH
Coloplast A/S
Gastroenterology & Urology · 232d
Cleared Feb 13, 2023
AmeriWater MediQA Reverse Osmosis System (MSP3HF)
K223656 · FIP
AmeriWater, LLC
Gastroenterology & Urology · 69d