DeviceClearance

Product code PCV— Gastroenterology, Urology

AUTOMATED ENDOSCOPE LEAK TESTER

Classification name
Endoscopic Leak Tester
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PCV under 21 CFR 876.1500, via openFDA

Market context for product code PCV

FDA has cleared 2 devices under product code PCV between 2013 and 2021, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PCV

Recent clearances under product code PCV

Data sourced from openFDA. This site is unofficial and independent of the FDA.