BEUDAMED
    Product Code: KOY FDA class 1 21 CFR 878.4730

    Degreaser, Skin, Surgical

    General, Plastic Surgery

    This device is a surgical skin degreaser used to remove oils and contaminants from the skin surface prior to surgical procedures or the application of adhesives or dressings. It is classified as FDA Class 1, the lowest risk designation, subject to general controls only. The product code is KOY, regulated under 21 CFR 878.4730 within the General and Plastic Surgery specialty. No special flags apply.

    View on FDA
    510(k)s
    0
    FEI Numbers
    16
    Registration Numbers
    16
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    KOY
    Device Class
    FDA class 1
    Regulation Number
    878.4730
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.