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

    TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE

    K Number: K121264 · Decision Aug 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    64
    Applicant Total
    1
    Review Days
    123

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    Basic Information

    Device Name
    TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE
    K Number
    K121264
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4310
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Surgical Technologies
    Date Received
    April 26, 2012
    Decision Date
    August 27, 2012
    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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