BEUDAMED
    Product Code: MGO FDA class 1 21 CFR 878.4018

    Closure, Wound, Adhesive

    General, Plastic Surgery

    The adhesive wound closure is a general and plastic surgery device that uses tissue adhesive to approximate wound edges in lieu of or as an adjunct to sutures or staples, providing a non-invasive method of wound closure for lacerations and surgical incisions. It is classified as FDA Class I under 21 CFR 878.4018 within the General and Plastic Surgery specialty, subject only to general controls. The product code is MGO and the device is not GMP-exempt. It is not implanted and does not sustain life.

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    510(k)s
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    MGO
    Device Class
    FDA class 1
    Regulation Number
    878.4018
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K912472 DEROYAL WOUND DRESSING

    FEI Numbers

    This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.