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..
FDA 510(k) Cleared Endoscopic Leak Tester Devices (Product Code PCV)
About Product Code PCV - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code PCV since 2013, with 2 receiving FDA clearance (average review time: 71 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
PCV devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →