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

    Utepreva Endometrial Sampler (UP01)

    K Number: K240595 · Decision Aug 14, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    163

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    Basic Information

    Device Name
    Utepreva Endometrial Sampler (UP01)
    K Number
    K240595
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1100
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Utepreva, LLC
    Date Received
    March 4, 2024
    Decision Date
    August 14, 2024
    Product Code
    HFE
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HFE Brush, Endometrial

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