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

    SURGISEAL TWIST TOPICAL SKIN ADHESIVE

    K Number: K141215 · Decision Aug 21, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    35
    Applicant Total
    10
    Review Days
    101

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    Basic Information

    Device Name
    SURGISEAL TWIST TOPICAL SKIN ADHESIVE
    K Number
    K141215
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4010
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Adhezion Biomedical, LLC
    Date Received
    May 12, 2014
    Decision Date
    August 21, 2014
    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
    K223669 SecurePortIV Advanced Catheter Securement Adhesive
    K170505 SecurePortIV Catheter Securement Adhesive
    K161011 SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive
    K150866 SURGISEAL Topical Skin Adhesvie
    K133963 SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE
    K140517 SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE
    K130329 SURGISEAL TOPICAL SKIN ADHESIVE
    K130474 SURGISEAL TOPICAL SKIN ADHESIVE
    K123936 SURGISEAL TOPICAL SKIN ADHESIVE