FDA Product Code PCV: Endoscopic Leak Tester
An Endoscopic Leak Tester Automatically Detects Leaks From Endoscopes, Without Requiring Visual Observation For Bubbles When The Device Is Immersed In Water, By Assessing Differences In Air Pressure Inside The Pressurized Endoscope.
Leading manufacturers include Pentax of America, Inc..
List of Endoscopic Leak Tester devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Endoscopic Leak Tester devices (product code PCV). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Gastroenterology & Urology FDA review panel. Browse all Gastroenterology & Urology devices →