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

    Uterine Aspiration Set

    K Number: K251882 · Decision Oct 16, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    41
    Applicant Total
    2
    Review Days
    118

    Basic Information

    Device Name
    Uterine Aspiration Set
    K Number
    K251882
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1175
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gcmedica Enterprise Ltd.(Wuxi)
    Date Received
    June 20, 2025
    Decision Date
    October 16, 2025
    Product Code
    HHK
    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
    HHK Curette, Suction, Endometrial (And Accessories)

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    Other Clearances by Gcmedica Enterprise Ltd.(Wuxi)

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