PCV — Endoscopic Leak Tester Class II

FDA Device Classification

Classification Details

Product Code: PCV
Device Class: Class II
Regulation Number: 876.1500
Submission Type
Review Panel: GU
Medical Specialty: Gastroenterology, Urology
Implant: No

Definition

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.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K212201	pentax of america	PENTAX Medical Auto Leakage Tester SHA-P6	October 1, 2021
K123704	olympus medical systems	AUTOMATED ENDOSCOPE LEAK TESTER	February 4, 2013