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510(k) Data Aggregation

    K Number
    K972267
    Device Name
    HELICA TC
    Manufacturer
    TENERCO, INC.
    Date Cleared
    1999-09-14

    (819 days)

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

    TENERCO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a helium gas electrosurgical coagulator for use in all soft tissue surgery--laparoscopic, endoscopic, and open.
    Device Description
    The 'TC' is a microprocessor controlled Helium Thermal Coagulator. Working at 2 to 33 watts of power with Helium gas flows of 1 to 5 liters/minute depending on procedure and probe. The 'TC' automatically works with all of the flexible disposable probes. Models T, C, D, E, R, and S. (Size range 2.5mm to 4mm x 60 mm to 310mm)
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