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U.S. Department of Health and Human Services

Product Classification
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Device endoscopic leak tester
Regulation Description Endoscope and accessories.
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.
Physical State Leak detection apparatus
Technical Method The device automatically detects leaks.
Target Area Flexible endoscopes.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePCV
Premarket Review Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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