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

    KARL STORZ NAV1 Electromagnetic Navigation System

    K Number: K161555 · Decision Oct 21, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    36
    Applicant Total
    25
    Review Days
    137

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    Basic Information

    Device Name
    KARL STORZ NAV1 Electromagnetic Navigation System
    K Number
    K161555
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Karl Storz Endoscopy America, Inc.
    Date Received
    June 6, 2016
    Decision Date
    October 21, 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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