BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Laparoscopic Contraceptive Tubal Occlusion Device

    PMA: P870076 · Supplement: S004 · Decision Jun 14, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Laparoscopic Contraceptive Tubal Occlusion Device
    Trade Name
    FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
    PMA Number
    P870076
    Supplement Number
    S004
    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
    June 14, 1996
    Date Received
    February 7, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ALTERNATE MANUFACTURING SITE ON CIRCON-CABOT MEDICAL'S RACINE, WISCONSIN FACILITY FOR 1) DISPOSABLE FALOPE-RING APPLICATOR KIT WITH 8MM TROCAR DISPOSABLE TROCAR, AND CANNULA: BOX OF 8 STERILE PROCEDURE KITS (RE-ORDER NUMBER 005280-901); AND 2) DISPOSABLE FALOPE-RING APPLICATOR KIT WITHOUT 8MM TROCAR, DISPOSABLE TROCAR, AND CANNULA: BOX OF 8 STERILE PROCEDURE KITS (RE-ORDER NUMBER 006889-901)

    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