BEUDAMED
    Product Code: EZS FDA class 1 21 CFR 876.5900

    Appliance, Colostomy, Disposable

    Gastroenterology, Urology

    The Disposable Colostomy Appliance (product code EZS) is a single-use device consisting of a bag and skin barrier used to collect and contain intestinal output from a colostomy stoma. It is an FDA Class 1 device (lowest risk), requiring only general controls with no premarket notification needed. It is regulated under 21 CFR 876.5900 in the Gastroenterology and Urology specialty. No special flags apply.

    View on FDA
    510(k)s
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    EZS
    Device Class
    FDA class 1
    Regulation Number
    876.5900
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    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
    K780409 COLOPLAST-DURASEAL OSTOMY APPLIANCE

    FEI Numbers

    This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 29 registration numbers. Click on an entry to view related FDA registrations.