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    K Number
    K251882

    Validate with FDA (Live)

    Device Name
    Uterine Aspiration Set
    Manufacturer
    GCMEDICA ENTERPRISE LTD.(WUXI)
    Date Cleared
    2025-10-16

    (118 days)

    Product Code
    HHK
    Regulation Number
    884.1175
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K030935
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Uterine Aspiration Set is used with the vacuum system to aspirate transcervically the products of conception or menstruation from the uterus.

    Device Description

    The Uterine Aspiration Set consists of rigid/flexible uterine aspiration curette and uterine aspiration tubing set(Composed of uterine aspiration tubing, swivel handle and other components). Rigid/flexible uterine aspiration curette and uterine aspiration tubing set(including uterine aspiration tubing and swivel handle) are all disposable and supplied sterile.

    Rigid/Flexible Uterine Aspiration Curette
    The rigid/flexible uterine aspiration curette is mainly used to scrape and remove tissues in the endometrium or uterine cavity. Its tip is suitable for entering the uterine cavity and performing scraping operations.

    Uterine Aspiration Tubing Set
    The uterine aspiration tubing set is mainly used to generate negative pressure during the surgical process. It is usually connected at one end to a Rigid/Flexible Uterine Aspiration Curette for scraping operations, and at the other end to a suction device, and tissues are sucked out by negative pressure. The suction force can be adjusted by sliding the ring on the vacuum control hole.

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