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

    OWL URF-3AP

    K Number: K062758 · Decision Sep 27, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    36
    Applicant Total
    8
    Review Days
    12

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    Basic Information

    Device Name
    OWL URF-3AP
    K Number
    K062758
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diros Technology, Inc.
    Date Received
    September 15, 2006
    Decision Date
    September 27, 2006
    Product Code
    GXD
    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
    GXD Generator, Lesion, Radiofrequency

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    Other Clearances by Diros Technology, Inc.

    K Number Device Name
    K170708 OWL RF INSULATED CANNULAE
    K150371 Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH
    K141586 OWL CANNULAE
    K102566 OWL CANNULAE
    K110593 OWL RF PROBES
    K093185 OWL UNIVERSAL RF SYSTEM URF-3AP (ML)
    K021869 OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP