BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Tissue Adhesive For The Topical Approximation Of Skin

    PMA: P050013 · Decision Feb 16, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Tissue Adhesive For The Topical Approximation Of Skin
    Trade Name
    HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
    PMA Number
    P050013
    Device Class
    FDA Class 2
    Product Code
    MPN
    Generic Name
    Tissue adhesive for the topical approximation of skin
    Regulation Number
    878.4010
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    February 16, 2007
    Date Received
    March 25, 2005
    Expedited Review
    N
    Docket Number
    07M-0086

    Advisory Committee Statement

    APPROVAL FOR THE HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE. THE DEVICE IS INDICATED FOR TOPICAL APPLICATION TO HOLD CLOSED EASILY APPROXIMATED SKIN EDGES OF MINIMUM-TENSION WOUNDS FROM CLEAN SURGICAL INCISIONS AND SIMPLE, THOROUGHLY CLEANSED, TRAUMA-INDUCED LACERATIONS. HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE MAY BE USED IN CONJUNCTION WITH BUT NOT IN PLACE OF DERMAL SUTURES.

    Classifications

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

    Product Code Device Name
    MPN Tissue Adhesive For The Topical Approximation Of Skin