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

    CIONIC NEURAL SLEEVE (NS-200)

    K Number: K243828 · Decision May 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    60
    Applicant Total
    1
    Review Days
    140

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    Basic Information

    Device Name
    CIONIC NEURAL SLEEVE (NS-200)
    K Number
    K243828
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5810
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cionic, Inc.
    Date Received
    December 13, 2024
    Decision Date
    May 2, 2025
    Product Code
    GZI
    Advisory Committee
    Neurology
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GZI Stimulator, Neuromuscular, External Functional

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