BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    OWL RF PROBES

    K Number: K110593 · Decision May 5, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    65
    Applicant Total
    8
    Review Days
    64

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    Basic Information

    Device Name
    OWL RF PROBES
    K Number
    K110593
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4725
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diros Technology, Inc.
    Date Received
    March 2, 2011
    Decision Date
    May 5, 2011
    Product Code
    GXI
    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
    GXI Probe, Radiofrequency Lesion

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