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

    Nutrifit

    K Number: K243361 · Decision Dec 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    47
    Same Product Code
    58
    Applicant Total
    4
    Review Days
    51

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    Basic Information

    Device Name
    Nutrifit
    K Number
    K243361
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vygon USA
    Date Received
    October 29, 2024
    Decision Date
    December 19, 2024
    Product Code
    FPD
    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
    FPD Tube, Feeding

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