BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Laparoscopic Contraceptive Tubal Occlusion Device

    PMA: P870076 · Supplement: S019 · Decision Jan 27, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Laparoscopic Contraceptive Tubal Occlusion Device
    Trade Name
    DISPOSABLE FALOPE-RING BAND APPLICATOR KITS
    PMA Number
    P870076
    Supplement Number
    S019
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 27, 2016
    Date Received
    December 28, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN SUPPLIERS FROM SENIOR OPERATIONS LLC (FORMERLY KNOWN AS GORMAC PRODUCTS) TO GYRUS ACMI NORWALK, OH FACILITY (ESTABLISHMENT REGISTRATION NUMBER 1519132) FOR THE MANUFACTURE OF THE FOLLOWING COMPONENTS OF YOUR DEVICE: FALOPE RING BAND APPLICATOR FORCEPS INNER TUBE (PART NUMBER 005261); OUTER TUBE (PART NUMBER 005262); AND CANNULA SLEEVE (PART NUMBER 004557-3).

    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