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

    Racz Neurostat RF Generator

    K Number: K232632 · Decision May 24, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    36
    Applicant Total
    2
    Review Days
    268

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    Basic Information

    Device Name
    Racz Neurostat RF Generator
    K Number
    K232632
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Epimed International
    Date Received
    August 30, 2023
    Decision Date
    May 24, 2024
    Product Code
    GXD
    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
    GXD Generator, Lesion, Radiofrequency

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    Other Clearances by Epimed International

    K Number Device Name
    K072005 RK EPIDURAL NEEDLE