BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT

    K Number: K053244 · Decision May 10, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    29
    Review Days
    170

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    Basic Information

    Device Name
    LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
    K Number
    K053244
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integra Lifesciences Corp.
    Date Received
    November 21, 2005
    Decision Date
    May 10, 2006
    Product Code
    GWM
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GWM Device, Monitoring, Intracranial Pressure

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