BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇬🇧 United Kingdom

    Eroxon

    K Number: DEN220078 · Decision Jun 9, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    231

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    Basic Information

    Device Name
    Eroxon
    K Number
    DEN220078
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    876.5021
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Futura Medical Developments Limited
    Date Received
    October 21, 2022
    Decision Date
    June 9, 2023
    Product Code
    QWW
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QWW Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.