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510(k) Data Aggregation

    K Number
    K984101
    Device Name
    FLEXIBLADE
    Manufacturer
    ARCO MEDIC LTD.
    Date Cleared
    1999-09-03

    (290 days)

    Product Code
    CCW
    Regulation Number
    868.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARCO MEDIC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flexiblade™ - Flexible Laryngoscope is intended for use as an aid for placement of tracheal tube and examination and visualization of patient's upper airway.
    Device Description
    The Flexiblade™ is a rigid laryngoscope featuring a flexible blade. The flexibility of the blade is achieved as a result of the motion of a trigger on the larvngoscope handle that its front end is fixed to the front part of the blade and its rear end is free. This control over the blade flexibility allows the operator performing intubation to place the blade end exactly in the vallecula area elevating the epiglottis with his/her fingers (by gently squeezing the trigger) without changing the device position.
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