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
625–648 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared May 26, 2023
Niti-S Biliary Speed D Stent
K223626 · FGE
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 172d
Cleared May 22, 2023
PVC Hydrophilic Urethral Catheter
K220722 · EZD
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 434d
Cleared May 19, 2023
GI Genius System 100 and GI Genius System 200
K231143 · QNP
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology · 28d
Cleared May 19, 2023
PrevisEA Device
K230769 · DQD
Entac Medical, Inc.
Gastroenterology & Urology · 60d
Cleared May 18, 2023
Single-Use Flexible Ureteroscope
K230200 · FGB
Hunan Vathin Medical Instrument Co.,...
Gastroenterology & Urology · 113d
Cleared May 11, 2023
FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL...
K220721 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 423d
Cleared May 05, 2023
ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA...
K220781 · EZN
Allwin Medical Devices, Inc.
Gastroenterology & Urology · 414d
Cleared May 04, 2023
SOZO Pro
K230531 · QJB
ImpediMed Limited
Gastroenterology & Urology · 66d
Cleared May 04, 2023
SOZO Pro
K230530 · OBH
ImpediMed Limited
Gastroenterology & Urology · 66d
Cleared May 04, 2023
SimPro™ Now, GentleCath™ Hydrophilic
K223756 · EZD
Dentsply Sirona
Gastroenterology & Urology · 140d
Cleared May 03, 2023
Sphincterotome
K222421 · KNS
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 265d
Cleared May 02, 2023
ASEPT Peritoneal Drainage System
K221779 · PNG
Pfm Medical, Inc.
Gastroenterology & Urology · 315d
Cleared May 01, 2023
vPATCH
K223595 · QRC
Virility Medical , Ltd.
Gastroenterology & Urology · 150d
Cleared Apr 27, 2023
Gastric Alimetry System
K223398 · MYE
Alimetry , Ltd.
Gastroenterology & Urology · 170d
Cleared Apr 26, 2023
EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS...
K222584 · FET
Olympus Medical Systems Corporation
Gastroenterology & Urology · 243d
Cleared Apr 25, 2023
MiVu™ Esophageal Endo Cap
K230056 · QIS
Diversatek Healthcare
Gastroenterology & Urology · 106d
Cleared Apr 20, 2023
Flexible Video-Choledochoscope System
K222261 · FBN
Shanghai SeeGen Photoelectric...
Gastroenterology & Urology · 266d
Cleared Apr 14, 2023
EndoflipTM 300
K223705 · FFX
Covidien, LLC
Gastroenterology & Urology · 123d
Cleared Apr 13, 2023
NaviCam Xpress Stomach System, NaviCam Xpress System
K230694 · QKZ
Anx Robotica Corp
Gastroenterology & Urology · 31d
Cleared Apr 07, 2023
SKOUT® system
K230658 · QNP
Iterative Scopes, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 05, 2023
Optimos™ Cystotome
K223256 · KNS
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 166d
Cleared Apr 05, 2023
Intermittent nelaton catheter for single use
K222677 · EZD
Hangzhou Jimushi Meditech Co., Ltd.
Gastroenterology & Urology · 211d
Cleared Apr 03, 2023
Sclerotherapy & Endoscopic Needles
K222006 · FBK
G-Flex Europe Sprl
Gastroenterology & Urology · 270d
Cleared Apr 03, 2023
Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile...
K220454 · NAM
Avation Medical, Inc.
Gastroenterology & Urology · 410d