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510(k) Data Aggregation

    K Number
    K150824
    Device Name
    TD-Wand
    Manufacturer
    Date Cleared
    2015-05-28

    (57 days)

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

    TDM SURGITECH, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TDM SurgiTech TD-Wand is intended for use in procedures that require precise cuts where only light or no hemostasis is desired using the cut mode and procedures where a greater level of hemostasis is desired using the coag and blend modes.
    Device Description
    TDM SurgiTech, Inc. ("TDMi")'s TD-Wand is a sterile, single use, disposable, monopolar device for use only with IEC 60601-1 certified electrosurgical units ("ESUs") that accept 3-pinned connectors. The TD-Wand combines blunt dissection with electrosection and electrocoagulation at its ceramic tip. The ceramic tip's bulbs provide blunt dissection capabilities between tissue planes similar to a cannula, bulbous scissors, or other blunt instrument. As such, initiation of the dissection path may be facilitated with the use of traditional surgical instruments. The device employs two types of recessed stainless steel electrodes that distribute electrosurgical current: (1) For cutting, the Cutting Electrode is comprised of 3 segments protectively recessed between four ceramic bulbs at the axial tip. When activated, the Cutting Electrode, along its 3 recessed segments, distributes a cut or blended cut/coag waveform yielding a cutting effect that may also have a hemostatic effect depending upon the "blended" waveform chosen. (2) For coagulation, the Coagulation Electrode, via the 7 termini protectively recessed atop the ceramic domes in the chevron shape, distributes coagulation waveforms producing a disbursed surface coagulation effect.
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