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510(k) Data Aggregation

    K Number
    K964621
    Device Name
    A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON
    Date Cleared
    1996-12-20

    (32 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALTO DEVELOPMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For use with electrosurgical generators that have the accessory finger tip activation feature to control bleeding through the use of suction and cautery.
    Device Description
    The monopolar electrosurgical device consists of an electrically conducting cannula which has plastic electrical insulation on it's exterior surface. This cannula fits into a plastic handle that has a central axial passage in line with the suction hole of the cannula. This suction hole leads to a suction hose fitting molded into the aft end of the handle. During use a hose connected to an external suction source is connected to the handle's suction fitting to provide suction to the cannula. A bleed hole in the handle allows the surgeon to control the amount of suction with his fingertip. High frequency power is supplied to the device through a 10 foot long power cord which enters the aft end of the handle and is internally connected to the cannula and switching circuitry. The distal end of the power cord has a standard plug that fits into most electrosurgical generators that have the accessory fingertip control option. The surgeon activates the cautery tip by pressing a push button located near the suction bleed hole. The new device will be marketed in cannula french size 10 with a 6 inch length.
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