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510(k) Data Aggregation

    K Number
    K031482
    Device Name
    CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE
    Manufacturer
    CRYOMEDICAL INSTRUEMTS LTD.
    Date Cleared
    2003-07-10

    (59 days)

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

    CRYOMEDICAL INSTRUEMTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CryoStar™ System is a cryoanalgesia device intended for use in blocking pain by temporarily ablating the peripheral nerves.
    Device Description
    The CryoStar™ system consists of a range of cryoprobes that are used for freezing nerves to block pain by temporary ablation. A console is used to house and control the supply of gas to the cryoprobe and to provide an electrical nerve location device. A footswitch completes the system. A convenience procedure kit for probe placement is also provided as a single use disposable. In the CryoStar™ system, compressed nitrous oxide or carbon dioxide is directed to the tip of the cryoprobe where it is allowed to expand through a fine annular space. The expansion of the gas to near atmospheric pressure causes cooling by the loule Thompson effect. The design of the cryoprobes is such that the warmer incoming gas maintains the outer stem of the cryoprobe above freezing temperatures to prevent freezing up the stem of the cryoprobe and unwanted tissue damage. A peripheral nerve stimulator in the CryoStar™ console facilitates the location of the peripheral nerve prior to freezing. Freezing of the nerve fibers creates a block which prevents the conduction of pain. The effect is usually non-permanent, and a repeat of the treatment may be necessary to deal with long term pain. The CryoStar™ console has been designed to provide a simple user interface, together with a series of error detection and warning systems to ensure proper operation. The pedestal of the console provides a convenient small footprint mobile base for the system, and houses up to four gas tanks. A simple footswitch completes the system.
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