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

    XK-95 HIGH SPEED MOTOR DRILL SYSTEM

    K Number: K984035 · Decision Jun 3, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    64
    Applicant Total
    3
    Review Days
    203

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    Basic Information

    Device Name
    XK-95 HIGH SPEED MOTOR DRILL SYSTEM
    K Number
    K984035
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4310
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Komet Medical
    Date Received
    November 12, 1998
    Decision Date
    June 3, 1999
    Product Code
    HBE
    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
    HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

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    Other Clearances by Komet Medical

    K Number Device Name
    K991625 KOMET XK-95 PERFORATOR MOTOR (MI-102)
    K943758 SURGICAL BUR