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510(k) Data Aggregation

    K Number
    K230849
    Device Name
    ELLAVI UBT
    Manufacturer
    SINAPI Biomedical (Pty) Ltd.
    Date Cleared
    2023-11-13

    (230 days)

    Product Code
    OQY
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    SINAPI Biomedical (Pty) Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ELLAVI UBT device is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
    Device Description
    The ELLAVI UBT is an 18 cm long intrauterine balloon tamponade device primarily comprised of thermoplastic elastomer. The balloon and internal tubing are made of thermoplastic elastomer, while the exterior tubing is made of polyvinyl chloride. A supply bag is the filled, connected, and hung at a pre-determined height based on the patient's systolic blood pressure. The device consists of a balloon that is inserted into the uterus transvaginally into the postpartum uterus after delivery and removal of the placenta. A valve is then opened, and this allows the fluid to inflate the balloon and apply pressure to achieve a hemostatic effect.
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