BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    ASPIVIX v1.1 Cervical Suction Tenaculum

    K Number: K203820 · Decision Aug 17, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    231

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    Basic Information

    Device Name
    ASPIVIX v1.1 Cervical Suction Tenaculum
    K Number
    K203820
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aspivix SA
    Date Received
    December 29, 2020
    Decision Date
    August 17, 2021
    Product Code
    HDC
    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
    HDC Tenaculum, Uterine

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    Other Clearances by Aspivix SA

    K Number Device Name
    K223866 Carevix™ Suction Cervical Stabilizer