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

    DERMABOND PRINEO Skin Closure System

    K Number: K213512 · Decision Dec 7, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    8
    Applicant Total
    204
    Review Days
    35

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    Basic Information

    Device Name
    DERMABOND PRINEO Skin Closure System
    K Number
    K213512
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4011
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ETHICON, Inc.
    Date Received
    November 2, 2021
    Decision Date
    December 7, 2021
    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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    DERMABOND PRINEO Skin Closure System

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    DERMABOND PRINEO Skin Closure System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by ETHICON, Inc.

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    K201996 Monocryl Plus Antibacterial Suture
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