PCVClass II
Endoscopic Leak Tester
Gastroenterology, Urology · 21 CFR 876.1500
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.
MDR events2All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances2All time
Recent MDR events
2 adverse event reports on file
Event type breakdown
Injury2
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
2 clearances for this product code