BEUDAMED
    Product Code: EXX FDA class 1 21 CFR 876.4730

    Probe, Rectal, Non-Powered

    Gastroenterology, Urology

    The non-powered rectal probe is a diagnostic instrument manually inserted into the rectum to assess rectal anatomy, palpate structures, or assist in therapeutic maneuvers in gastroenterology and urology procedures. It is classified as FDA Class 1, the lowest risk category, requiring only general controls and no premarket submission. The product code is EXX, regulated under 21 CFR 876.4730 in the Gastroenterology, Urology specialty. No special regulatory flags apply.

    View on FDA
    510(k)s
    0
    FEI Numbers
    41
    Registration Numbers
    41
    Unique Applicants
    0
    Years Active
    —

    Research product code EXX in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    EXX
    Device Class
    FDA class 1
    Regulation Number
    876.4730
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 41 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 41 registration numbers. Click on an entry to view related FDA registrations.