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

    Carevix™ Suction Cervical Stabilizer

    K Number: K223866 · Decision Jan 25, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    33

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Carevix™ Suction Cervical Stabilizer
    K Number
    K223866
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aspivix SA
    Date Received
    December 23, 2022
    Decision Date
    January 25, 2023
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HDC), ordered by most recent decision date.

    ASPIVIX v1.1 Cervical Suction Tenaculum

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Bioceptive Suction Cervical Retractor

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    JARIT HULKA UTERINE TENACULUM FORCEPS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    GYN DISPOSABLES TENACULUM 356T

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    FEMTEN CERVICAL TENACULUM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BURBANK TENACULUM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Aspivix SA

    K Number Device Name
    K203820 ASPIVIX v1.1 Cervical Suction Tenaculum