BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Fiagon Navigation System

    K Number: K163209 · Decision Sep 14, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    16
    Review Days
    303

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    Basic Information

    Device Name
    Fiagon Navigation System
    K Number
    K163209
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fiagon GmbH
    Date Received
    November 15, 2016
    Decision Date
    September 14, 2017
    Product Code
    HAW
    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
    HAW Neurological Stereotaxic Instrument

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    Other Clearances by Fiagon GmbH

    K Number Device Name
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    K201472 VenSure Balloon Device, VenSure Nav Balloon Device
    K200041 FlexPointer 1.5 Single Use, FlexTube 3 Single Use
    K163416 Fiagon Navigation – PointerTube Straight and PointerTube Keat
    K162176 Fiagon Navigation System
    K161940 Guidewire 0.6 Single Use
    K151156 Fiagon Navigation System
    Search all 16 clearances from Fiagon GmbH →