BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SURGISEAL TOPICAL SKIN ADHESIVE

    K Number: K130474 · Decision May 31, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    33
    Applicant Total
    8
    Review Days
    95

    Basic Information

    Device Name
    SURGISEAL TOPICAL SKIN ADHESIVE
    K Number
    K130474
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4010
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Adhezion Biomedical, LLC
    Date Received
    February 25, 2013
    Decision Date
    May 31, 2013
    Product Code
    MPN
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

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

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    Other Clearances by Adhezion Biomedical, LLC

    K Number Device Name
    K170505 SecurePortIV Catheter Securement Adhesive
    K161011 SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive
    K133963 SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE
    K141215 SURGISEAL TWIST TOPICAL SKIN ADHESIVE
    K140517 SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE
    K130329 SURGISEAL TOPICAL SKIN ADHESIVE
    K123936 SURGISEAL TOPICAL SKIN ADHESIVE