BEUDAMED
    Product Code: KGT FDA class 1 21 CFR 878.4380

    Drape, Adhesive, Aerosol

    General, Plastic Surgery

    Aerosol Adhesive Drape is a surgical draping product applied as a spray to the patient's skin or to the edges of surgical drapes, creating a film that adheres the drape to the skin surface and helps maintain sterile field integrity during operative procedures. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KGT, regulated under 21 CFR 878.4380, within the General, Plastic Surgery medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    KGT
    Device Class
    FDA class 1
    Regulation Number
    878.4380
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    HO
    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
    K851612 DERMA PREP

    FEI Numbers

    This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.