Endoscopic Leak Tester
- US Product Code (FDA)
- PCVView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 876.1500View CFR Regulation →
- Medical specialty
- Gastroenterology, Urology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
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.
Click to search for similar devices in our global database
Endoscopic Leak Tester is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.