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

    GYRUS ENT NERVE STIMULATOR

    K Number: K021595 · Decision Oct 24, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    96
    Applicant Total
    28
    Review Days
    162

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    Basic Information

    Device Name
    GYRUS ENT NERVE STIMULATOR
    K Number
    K021595
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gyrus Ent LLC
    Date Received
    May 15, 2002
    Decision Date
    October 24, 2002
    Product Code
    ETN
    Advisory Committee
    Ear, Nose, Throat
    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
    ETN Stimulator, Nerve

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    Other Clearances by Gyrus Ent LLC

    K Number Device Name
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    K030343 DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE
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    K020778 GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420
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    Search all 28 clearances from Gyrus Ent LLC →