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

    Intracept Intraosseous Nerve Ablation System

    K Number: K213836 · Decision Mar 11, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    62
    Applicant Total
    2
    Review Days
    92

    Basic Information

    Device Name
    Intracept Intraosseous Nerve Ablation System
    K Number
    K213836
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4725
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Relievant Medsystems, Inc.
    Date Received
    December 9, 2021
    Decision Date
    March 11, 2022
    Product Code
    GXI
    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
    GXI Probe, Radiofrequency Lesion

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    Other Clearances by Relievant Medsystems, Inc.

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