PCV · Class II · 21 CFR 876.1500

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 Olympus Medical Systems Corp. and Pentax of America, Inc..

2
Total
2
Cleared
71d
Avg days
2013
Since

FDA 510(k) Cleared Endoscopic Leak Tester Devices (Product Code PCV)

2 devices
1–2 of 2
Cleared Oct 01, 2021
PENTAX Medical Auto Leakage Tester SHA-P6
K212201
Pentax of America, Inc.
Gastroenterology & Urology · 79d
Cleared Feb 04, 2013
AUTOMATED ENDOSCOPE LEAK TESTER
K123704
Olympus Medical Systems Corp.
Gastroenterology & Urology · 63d

About Product Code PCV - Regulatory Context