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

    OWL UNIVERSAL RF SYSTEM URF-3AP (ML)

    K Number: K093185 · Decision Jan 22, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    36
    Applicant Total
    8
    Review Days
    105

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    Basic Information

    Device Name
    OWL UNIVERSAL RF SYSTEM URF-3AP (ML)
    K Number
    K093185
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diros Technology, Inc.
    Date Received
    October 9, 2009
    Decision Date
    January 22, 2010
    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
    K062758 OWL URF-3AP
    K021869 OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP