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510(k) Data Aggregation

    K Number
    K203820
    Device Name
    ASPIVIX v1.1 Cervical Suction Tenaculum
    Manufacturer
    Aspivix S.A.
    Date Cleared
    2021-08-17

    (231 days)

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

    Aspivix S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ASPIVIX v1.1 Cervical Suction Tenaculum is indicated to snare, grasp, hold and manipulate cervical tissue.
    Device Description
    ASPIVIX v1.1 is a sterile, single-use, one-piece device that consists of four non-removable parts: a reloadable vacuum reserve embedded inside the main body, an activation / deactivation slider ring, a sliding tube to generate vacuum in the main body and an anatomic suction pad to put in contact with the cervix.
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