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510(k) Data Aggregation

    K Number
    K023173
    Device Name
    ANDREWS INTRODUCER, MODEL ASI01
    Manufacturer
    ANDREWS SURGICAL INNOVATIONS, LTD.
    Date Cleared
    2002-12-18

    (86 days)

    Product Code
    MDM
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANDREWS SURGICAL INNOVATIONS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Andrews Introducer™ is specifically designed for the insertion of intercostal chest tubes.
    Device Description
    The Andrews Introducer™ is a reusable surgical forceps made of surgical steel that is specifically designed for the insertion of chest tubes. The Andrews Introducer™ is a three-limbed forceps and has three major features: 1. A pivot joint at the fulcrum that opens the tips when the handles are closed using the stronger gripping force of the hand. The extent to which the tips open has been limited so as to reduce the trauma to the intercostal muscle. 2. A vertical extension on each blade that creates a circular channel which is more accurately and appropriately shaped to allow easy passage of the chest tube. The distance between the vertical blades at the fulcrum is 10.7 millimetres, sufficient-to accommodate the diameter of a 32 gauge chest tube, expanding to 22mm at the. 3. A third limb that is attached to the two main limbs through the pivot joint. It is held equidistant from the two main limbs by two leaf springs, which also close the tips when force is relieved from the handles. There is also a grip on the distal end of the third limb to hold the chest tube in position on the instrument for more rapid insertion once the channel has been created.
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