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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 To be used to perform and record leakage testing on flexible endoscopes.
Physical State The test results are displayed on an LCD monitor. In the MLT mode, the operator determines whether the endoscope has a pinhole by monitoring air bubbles from the endoscope soaked in water. It also uses RFID for recognizing endoscopes and operators and has a recording function to store test results for printing as needed. It has a guiding function and self-check function.
Technical Method The tester uses two testing modes: (1) automated leak test mode (ALT mode), (2) manual leak test mode (MLT mode). The device detects leaks from the differences in air pressure.
Target Area flexible endoscopes.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePCV
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Urology and Lithotripsy Devices Branch (ULDB)
Submission Type 510(k)
Regulation Number 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible