BEUDAMED
    Product Code: MKY FDA class 1 21 CFR 878.4320

    System, Skin Closure

    General, Plastic Surgery

    The Skin Closure System is a wound closure device, typically consisting of adhesive strips, tapes, or similar materials, used to hold the edges of skin wounds or surgical incisions together to promote healing without the use of sutures or staples. Classified as a Class 1 device under 21 CFR 878.4320 in the General and Plastic Surgery specialty, it is subject only to general controls and is generally exempt from 510(k) premarket notification. It carries no implant or life-sustaining flags.

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    510(k)s
    6
    FEI Numbers
    30
    Registration Numbers
    30
    Unique Applicants
    4
    Years Active
    7

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    Basic Information

    Product Code
    MKY
    Device Class
    FDA class 1
    Regulation Number
    878.4320
    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 6 510(k) clearances via K numbers.

    K Number Device Name
    K002315 WISEBANDS SKIN CLOSURE DEVICE
    K982439 PROXIDERM, MODELS TN 460, TN 90 460, BK 460
    K970439 PROXIDERM (D-460,D 90 460,D 180,460, PS 460)
    K962144 PHOENIX ETE TISSUE EXTENSION SYSTEM
    K942425 PROXIDERM (TENTATIVE)
    K942526 SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 30 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 30 registration numbers. Click on an entry to view related FDA registrations.