BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇭🇰 Hong Kong

    ANDORATE® Suction Valve and ANDORATE® Biopsy Valve

    K Number: K230280 · Decision May 11, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    32
    Applicant Total
    12
    Review Days
    99

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    Basic Information

    Device Name
    ANDORATE® Suction Valve and ANDORATE® Biopsy Valve
    K Number
    K230280
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ga Health Company Limited
    Date Received
    February 1, 2023
    Decision Date
    May 11, 2023
    Product Code
    KTI
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KTI Bronchoscope Accessory

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    Other Clearances by Ga Health Company Limited

    K Number Device Name
    K232118 ANDORATE® Valve Kit
    K231602 Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing
    K230932 ANDORATE® Valve Kit
    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
    Search all 12 clearances from Ga Health Company Limited →