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
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Endoscopic Leak Tester Devices (Product Code PCV)
2 devices
Cleared
Oct 01, 2021
PENTAX Medical Auto Leakage Tester SHA-P6
Pentax of America, Inc.
Gastroenterology & Urology
79d
Cleared
Feb 04, 2013
AUTOMATED ENDOSCOPE LEAK TESTER
Olympus Medical Systems Corp.
Gastroenterology & Urology
63d
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.