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510(k) Data Aggregation

    K Number
    K060928
    Device Name
    CRYOSHAPE
    Manufacturer
    ETGAR GROUP H.M.Y.A. LTD.
    Date Cleared
    2006-05-22

    (48 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    ETGAR GROUP H.M.Y.A. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CryoShape is intended to destroy tissue during surgical procedures by applying extreme cold.
    Device Description
    The CryoNeedle Cryoprobe manufactured by Etgar Group H.M.Y.A. Ltd. (U.S Patent 6.503,246) is a hand-held cryosurgical instrument for destroving tissue during surgical procedures by intralesional application of extremely cold cryoprobe. The device is based on intralesional application of a needle cooled by the cryogenic fluid (liquid nitrogen with boiling temperature -196℃ (-320.8ºF)) to a selected area to effect cellular destruction. . The needle is cooled by the cryogenic fluid (liquid nitrogen - boiling temperature -196°C (-320.8°F)) is applied intralesionally to a selected area to effect cellular destruction. By forcing liquid nitrogen to circulate through the needle an ice ball around the CryoNeedle developed causing the abutted HSK tissue to be completely frozen. As this iceball grows, its leading edge advances through tissue. Tissue that comes into contact with the iceball is destroyed. Temperatures of -25℃ to -50℃ (-139F to -58°F) are achieved within 30 seconds.
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