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

    Laparoscopic Contraceptive Tubal Occlusion Device

    PMA: P870076 · Supplement: S021 · Decision Mar 2, 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
    S021
    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
    March 2, 2016
    Date Received
    February 4, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change in supplier from Senior Operations LLC (formerly known as GA MFG Precision) to XL Precision for the manufacture of the Trocar Knife (Part No. 004556-503) and a manufacturing process change to produce a one-piece configuration Trocar Knife.

    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