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510(k) Data Aggregation

    K Number
    K211334
    Device Name
    Iovera System
    Manufacturer
    Pacira Pharmaceuticals Inc.
    Date Cleared
    2021-09-10

    (130 days)

    Product Code
    GXH
    Regulation Number
    882.4250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pacira Pharmaceuticals Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iovera? system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The ioveraº system is not indicated for treatment of central nervous system tissue.
    Device Description
    The iovera° system is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue through application of extreme cold to the selected site. The device is based on introduction of a Smart Tip internally cooled by the cryogenic fluid (nitrous oxide, N₂O) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or latent heat of vaporization. The device comprises four main components: A reusable Handpiece, A Charging Dock, An assortment of single-patient-use Smart Tips, A Cartridge containing nitrous oxide.
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