BEUDAMED
    Product Code: EYY FDA class 2 21 CFR 878.4370

    Drape, Urological, Disposable

    General, Plastic Surgery

    The Disposable Urological Drape (product code EYY) is a single-use surgical drape designed to maintain a sterile field during urological procedures. It falls under FDA Class 2 (moderate risk), meaning manufacturers must demonstrate substantial equivalence through a 510(k) premarket notification before marketing. It is regulated under 21 CFR 878.4370 within the General and Plastic Surgery specialty. No special flags apply to this device.

    View on FDA
    510(k)s
    2
    FEI Numbers
    32
    Registration Numbers
    32
    Unique Applicants
    2
    Years Active
    4

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    Basic Information

    Product Code
    EYY
    Device Class
    FDA class 2
    Regulation Number
    878.4370
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K851675 THE PERCUTANEOUS NEPHROSTOLITHOTOMY DRAPE
    K810291 STERILE/DISPOSABLE HSG TRAY

    FEI Numbers

    This FDA classification entry is associated with 32 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 32 registration numbers. Click on an entry to view related FDA registrations.