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510(k) Data Aggregation

    K Number
    K212201
    Device Name
    PENTAX Medical Auto Leakage Tester SHA-P6
    Date Cleared
    2021-10-01

    (79 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    PCV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PENTAX Medical Auto Leakage Tester SHA-P6 is intended to perform leakage testing on PENTAX Medical flexible endoscopes.
    Device Description
    PENTAX Medical Auto Leakage Tester SHA-P6 (Hereinafter "the Device") is intended to be used to perform leakage testing on PENTAX Medical flexible endoscopes are complex devices that consist of various mechanical, optical, and video elements that might be affected by exposure to fluid. Therefore, endoscope leak testing is a crucial procedure for the proper endoscope cleaning and disinfecting process. The Device is designed to detect leaks by measuring the difference in air pressure over time using the Automated Leak Test mode (ALT mode). The Device conducts two types of tests: a dry leakage test and a wet leakage test. The dry leakage test is performed when the device feeds air into the endoscope until a set pressure is reached, and then monitors the pressure over a specific period of time. The wet leakage test is conducted after confirming the absence of a leak during the dry leakage test, by immersing the endoscope in potable water to test for loss of integrity in its watertight construction. The Device is compatible with PENTAX Medical flexible endoscopes.
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    K Number
    K123704
    Device Name
    AUTOMATED ENDOSCOPE LEAK TESTER
    Date Cleared
    2013-02-04

    (63 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    PCV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This equipment is intended to be used to perform and record leakage testing on Olympus flexible endoscopes.
    Device Description
    The subject ALT-Y0003 is used to detect leaks from Olympus flexible endoscopes. It utilizes two testing modes; one is automated leak test mode (ALT mode) and the other is manual leak test mode (MLT mode). In ALT mode, it is not required to soak the tested endoscope in water. The ALT-Y0003 detects leak from the difference of air pressure. The ALT-Y0003 can also be used for conventional manual leak test by soaking an endoscope in water. The ALT-Y0003 has an RFID function to recognize endoscope and operator identification. It can store test results in its internal memory and this stored record can be printed out with the designated printer and/or transferred to deginated USB memory.
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