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510(k) Data Aggregation

    K Number
    K070509
    Device Name
    FISSO HOLDING SYSTEM
    Manufacturer
    BAITELLA AG
    Date Cleared
    2007-03-22

    (28 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    BAITELLA AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FISSO Holding System consists of a table-mounted endoscope holder system intended for use by surgeons to hold endoscopes and arthroscopes with a diameter of 4mm to 10mm during general diagnostic and therapeutic procedures. The device is also intended for use by qualified surgeons for holding endoscopes during diagnostic and therapeutic neurologic procedures
    Device Description
    Table-mounted self-retaining endoscope holder system consisting of stainless steel tubular, articulated arms that are connected to a vertical stand and are freely adjustable within the articulating radius according to the requirements of the particular surgical procedure. All joints are locked in position simultaneously via the adjustment knob located on the central joint. Accessories include endoscope holders for 4mm to 10mm scopes as well as multiple class-l holding devices. The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.
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