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

    DERMABOND PRINEO Skin Closure System

    K Number: K163645 · Decision Apr 21, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    119

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    Basic Information

    Device Name
    DERMABOND PRINEO Skin Closure System
    K Number
    K163645
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4011
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ethicon, LLC
    Date Received
    December 23, 2016
    Decision Date
    April 21, 2017
    Product Code
    OMD
    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
    OMD Cutaneous Tissue Adhesive With Mesh

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    Other Clearances by Ethicon, LLC

    K Number Device Name
    K153611 Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device