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

    Fusion Compact Navigation System

    K Number: K153247 · Decision Feb 18, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    34
    Applicant Total
    17
    Review Days
    101

    Basic Information

    Device Name
    Fusion Compact Navigation System
    K Number
    K153247
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MEDTRONIC NAVIGATION, INC.
    Date Received
    November 9, 2015
    Decision Date
    February 18, 2016
    Product Code
    PGW
    Advisory Committee
    Neurology
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PGW Ear, Nose, And Throat Stereotaxic Instrument

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