BEUDAMED
    Product Code: EXA FDA class 1 21 CFR 876.5900

    Selector, Size, Ostomy

    Gastroenterology, Urology

    The ostomy size selector is a measurement tool used by patients or clinicians to determine the appropriate stoma opening size for fitting ostomy pouching systems accurately. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket notification requirement. The product code is EXA, regulated under 21 CFR 876.5900 in the Gastroenterology, Urology specialty. No special regulatory flags apply.

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    510(k)s
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    EXA
    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
    K781736 DISC, COLOPLAST PRE-OP STOMA

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.