BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    ANDORATE® Valve Kit

    K Number: K232118 · Decision Oct 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    71
    Applicant Total
    12
    Review Days
    91

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    Basic Information

    Device Name
    ANDORATE® Valve Kit
    K Number
    K232118
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ga Health Company Limited
    Date Received
    July 17, 2023
    Decision Date
    October 16, 2023
    Product Code
    ODC
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ODC Endoscope Channel Accessory

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    Other Clearances by Ga Health Company Limited

    K Number Device Name
    K231602 Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing
    K230932 ANDORATE® Valve Kit
    K230280 ANDORATE® Suction Valve and ANDORATE® Biopsy Valve
    K223171 AquaPulse® Irrigation Tubing
    K213095 andorate Suction Valve, andorate Air/Water Valve
    K202838 Andorate Universal Endoscope Tip Guard
    K202560 AquaPulse Irrigation Tubing
    K200495 Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve
    K200481 Andorate Biopsy Valve, Andorate Biopsy Irrigator
    K200479 AquaPulse Auxiliary Water Connector
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