Endoscopic Leak Tester
The Endoscopic Leak Tester is a gastrointestinal device that automatically detects leaks from endoscopes without requiring visual observation for bubbles, providing a more reliable and standardized method of endoscope integrity testing. It falls under the Gastroenterology and Urology medical specialty and is classified as a Class 2 device under regulation 876.1500, requiring 510(k) premarket notification. Proper endoscope leak testing is critical for infection prevention and ensuring patient safety during endoscopic procedures. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PCV
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.