BEUDAMED
    Product Code: EYR FDA class 1 21 CFR 878.5900

    Tourniquet, Gastro-Urology

    General, Plastic Surgery

    The gastro-urology tourniquet is a device used to temporarily occlude blood vessels or restrict blood flow in the surgical field during urological or abdominal procedures, facilitating a bloodless operative environment. It is classified as FDA Class 1, indicating minimal risk, requiring only general controls and no premarket notification. The product code is EYR, regulated under 21 CFR 878.5900 in the General, Plastic Surgery specialty. No special regulatory flags apply.

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    510(k)s
    2
    FEI Numbers
    20
    Registration Numbers
    20
    Unique Applicants
    2
    Years Active
    1

    Basic Information

    Product Code
    EYR
    Device Class
    FDA class 1
    Regulation Number
    878.5900
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K802850 TECNOL O.R. TOURNIQUET COVER
    K792256 KEITHLEY CLAMP

    FEI Numbers

    This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.