BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Laparoscopic Contraceptive Tubal Occlusion Device

    PMA: P920046 · Supplement: S015 · Decision Dec 3, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Laparoscopic Contraceptive Tubal Occlusion Device
    Trade Name
    Filshie Clip (Mark VI) System
    PMA Number
    P920046
    Supplement Number
    S015
    Device Class
    FDA Class 3
    Product Code
    KNH
    Generic Name
    Laparoscopic contraceptive tubal occlusion device
    Regulation Number
    884.5380
    Medical Specialty
    Obstetrics/Gynecology
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 3, 2024
    Date Received
    September 5, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for revising the Instructions for Use (IFU) for the Filshie Clip to harmonize IFU labeling internationally.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNH Laparoscopic Contraceptive Tubal Occlusion Device