BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Laparoscopic Contraceptive Tubal Occlusion Device

    PMA: P870076 · Supplement: S017 · Decision Jul 20, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Laparoscopic Contraceptive Tubal Occlusion Device
    Trade Name
    FALOPE-RING BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
    PMA Number
    P870076
    Supplement Number
    S017
    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
    July 20, 2016
    Date Received
    November 2, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to recover and repackage intact and unused Disposable Falope-Ring® Band Applicators, subject them to a second sterilization process, and make them available for sale and distribution.

    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