BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Suture, Nonabsorbable, Silk

    PMA: N11397 · Supplement: S019 · Decision Dec 2, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    128

    Basic Information

    Device Name
    Suture, Nonabsorbable, Silk
    Trade Name
    SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP
    PMA Number
    N11397
    Supplement Number
    S019
    Device Class
    FDA Class 2
    Product Code
    GAP
    Generic Name
    Suture, nonabsorbable, silk
    Regulation Number
    878.5030
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 2, 1982
    Date Received
    October 18, 1982
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    GAP Suture, Nonabsorbable, Silk