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    K Number
    K223866
    Device Name
    Carevix™ Suction Cervical Stabilizer
    Manufacturer
    Aspivix SA
    Date Cleared
    2023-01-25

    (33 days)

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

    Aspivix SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Carevix™ Suction Cervical Stabilizer is indicated to snare, grasp, hold and manipulate cervical tissue.
    Device Description
    Carevix™ Suction Cervical Stabilizer is a sterile, single-use, two-piece device consisting of three main parts: a reloadable vacuum reserve embedded inside the main body, including a piston to generate the vacuum, an activation/deactivation push-button, and an anatomic-shaped suction head to put in contact with the cervix. The suction head includes a rod that connects the main body.
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