BEUDAMED
    Product Code: FXW FDA class 1 21 CFR 878.4040

    Shoes, Operating-Room

    General, Plastic Surgery

    Operating room shoes are specialized footwear designed for use in surgical environments, providing protection and comfort for surgical staff while reducing contamination risks within the sterile field. They are classified as FDA Class 1 (lowest risk), subject to general controls only, and do not require premarket notification. The product code is FXW, regulated under 21 CFR 878.4040, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

    View on FDA
    510(k)s
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    FXW
    Device Class
    FDA class 1
    Regulation Number
    878.4040
    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
    K923187 IMPERVIOUS ISOLATION SHOE COVERS

    FEI Numbers

    This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.