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
985–1008 of 9,917
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Apr 28, 2021
Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse...
K210925 · GEX
Boston Scientific
Gastroenterology & Urology · 30d
Cleared Apr 28, 2021
Oral/Enteral Syringe
K210621 · PNR
Ningbo Tianyi Medical Appliance Co.,...
Gastroenterology & Urology · 57d
Cleared Apr 27, 2021
Safety Trocar Cannula
K211072 · KNT
Boston Scientific Corporation
Gastroenterology & Urology · 15d
Cleared Apr 27, 2021
Stone Retrieval Balloon Catheter
K210660 · GCA
Anrei Medical (Hangzhou) Co., Ltd.
Gastroenterology & Urology · 54d
Cleared Apr 26, 2021
Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit,...
K200260 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 448d
Cleared Apr 21, 2021
DiLumen Endolumenal Interventional Platform (DiLumen)
K210851 · FDF
Lumendi, LLC
Gastroenterology & Urology · 30d
Cleared Apr 19, 2021
SOZO
K203473 · DSB
ImpediMed Limited
Gastroenterology & Urology · 145d
Cleared Apr 15, 2021
AXIOS Stent and Electrocautery Enhanced Delivery System
K203132 · PCU
Boston Scientific Corporation
Gastroenterology & Urology · 178d
Cleared Apr 13, 2021
Flyte
K210764 · HIR
Pelvital USA, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 12, 2021
Athena Surgical RMUS System
K210087 · OTN
Athena Surgical, LLC
Gastroenterology & Urology · 89d
Cleared Apr 09, 2021
PENTAX Medical Video Duedenoscope ED34-i10T2
K210710 · FDT
Pentax of America, Inc.
Gastroenterology & Urology · 30d
Cleared Apr 09, 2021
Endoscope Model EI-740D/S
K210162 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 78d
Cleared Apr 09, 2021
Enteral Feeding Catheter
K202748 · KNT
Medcaptain Life Science Co., Ltd.
Gastroenterology & Urology · 200d
Not Cleared Apr 09, 2021
GI Genius
DEN200055 · QNP
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology · 213d
Cleared Apr 08, 2021
Well Lead All Silicone Foley Catheter with Temperature Sensor
K202134 · EZL
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 251d
Cleared Apr 02, 2021
Pristine Long-Term Hemodialysis Catheter
K203767 · MSD
C B Bard, Inc.
Gastroenterology & Urology · 100d
Cleared Apr 01, 2021
Pentax Medical Video Duodenoscope ED32-i10
K202365 · FDT
Pentax of America, Inc.
Gastroenterology & Urology · 225d
Cleared Mar 30, 2021
Modulith SLX-F2
K201001 · LNS
Karl Storz Endoscopy America
Gastroenterology & Urology · 348d
Cleared Mar 24, 2021
ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube
K203133 · KNT
Envizion Medical , Ltd.
Gastroenterology & Urology · 156d
Cleared Mar 19, 2021
ZIDA Wearable Neuromodulation System
K192731 · NAM
Exodus Innovations
Gastroenterology & Urology · 539d
Cleared Mar 15, 2021
Ensure Single-Use Coagulation Forceps
K202438 · KGE
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 202d
Cleared Mar 11, 2021
AquaBeam Robotic System
K202961 · PZP
Procept Biorobotics, Corporation
Gastroenterology & Urology · 162d
Cleared Mar 10, 2021
NovaLine Tubing Sets for Hemodialysis
K201866 · FJK
Bain Medical Equipment (Guangzhou)...
Gastroenterology & Urology · 246d
Cleared Mar 10, 2021
AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory
K201809 · KDI
Baxter Healthcare Corportation
Gastroenterology & Urology · 252d