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

    gammaCore Sapphire

    K Number: K180538 · Decision Mar 30, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    8
    Applicant Total
    4
    Review Days
    30

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    Basic Information

    Device Name
    gammaCore Sapphire
    K Number
    K180538
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5892
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Electrocore, LLC
    Date Received
    February 28, 2018
    Decision Date
    March 30, 2018
    Product Code
    PKR
    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
    PKR Non-Invasive Vagus Nerve Stimulator - Headache

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    Other Clearances by Electrocore, LLC

    K Number Device Name
    K173442 gammaCore-S
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    DEN150048 gammaCore Non-invasive Vagus Nerve Stimulator