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510(k) Data Aggregation

    K Number
    K062350
    Device Name
    SURGINETICS ADVANTAGEBLADE
    Manufacturer
    SURGINETICS
    Date Cleared
    2007-02-26

    (199 days)

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

    SURGINETICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surginetics AdvantageBlade is intended as an alternative to uncoated stainless steel as well as coated electrodes for use in conventional monopolar electrosurgical accessories. The AdvantageBlade is intended for use in situations where monopolar electrosurgery is used. The Surginetics AdvantageBlade™ coated electrodes are indicated for use in surgical procedures (general, neurosurgical, laparoscopic, orthopedic, gynecologic, etc.) where monopolar electrosurgical cutting and coagulation are normally used. The coated electrodes are an alternative to conventional monopolar electrosurgical electrodes used for these indications.
    Device Description
    The Surginetics AdvantageBlade is a coated blade intended for use as a monopolar electrosurgical accessory. The blade reduces the smoke emitted into the surgical area, uses lower wattages with less tissue damage and the coating provides a surface that facilitates ease of cleaning of tissue residues that may accumulate during use. The coating provides for ease of eschar cleaning. The blades are intended for use with monopolar electrosurgical accessories and will be packaged separately. The coated blades will also fit in currently marketed electrosurgical pencils offered by other manufacturers.
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