BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Epitomee

    K Number: K240544 · Decision Sep 13, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    199

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    Basic Information

    Device Name
    Epitomee
    K Number
    K240544
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5982
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Epitomee Medical , Ltd.
    Date Received
    February 27, 2024
    Decision Date
    September 13, 2024
    Product Code
    QFQ
    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
    QFQ Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss

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