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

    Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)

    K Number: K243367 · Decision Jul 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    265

    Basic Information

    Device Name
    Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)
    K Number
    K243367
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Minnesota Medical Technologies
    Date Received
    October 30, 2024
    Decision Date
    July 22, 2025
    Product Code
    PBP
    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
    PBP Rectal Insert

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