Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K082584
    Device Name
    GIVEN ELECTROSURGICAL NEEDLE
    Date Cleared
    2009-10-28

    (415 days)

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

    TRIPPS COURT ENTERPRISES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Given Electrosurgical Needle is used to apply electrosurgical current directly into a spider vein located within the skin. The electrosurgical current destroys the spider vein.
    Device Description
    The Given Electrosurgical Needle is a single patient use needle electrode for use in monopolar electrosurgical handpieces. The skin which is usually anesthetized with a topical and/or injectable anesthetic. The monopolar generator is set at the cutting mode to 1.5 to 1.75 Watts. The needle is introduced into the vein located within the skin. The current is then applied with destruction of the vein while the insulation protects the surrounding tissue. The needle is withdrawn and additional veins are then treated in a similar fashion. The needle is made of Tungsten Carbide and the insulation is Parylene-C which are both biocompatible materials that have been used extensively in electrosurgical electrodes.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1