BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Manual Tissue Removal Device

    K Number: K254050 · Decision May 15, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    170
    Applicant Total
    2
    Review Days
    149

    Basic Information

    Device Name
    Manual Tissue Removal Device
    K Number
    K254050
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Suzhou AcuVu Medical Technology Co., Ltd.
    Date Received
    December 17, 2025
    Decision Date
    May 15, 2026
    Product Code
    HIH
    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
    HIH Hysteroscope (And Accessories)

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    Other Clearances by Suzhou AcuVu Medical Technology Co., Ltd.

    K Number Device Name
    K231260 HTx Disposable Hysteroscope System