BEUDAMED
    Product Code: FFQ FDA class 1 21 CFR 876.4730

    Speculum, Rectal

    Gastroenterology, Urology

    The Rectal Speculum is a rigid instrument used to spread and hold open the walls of the rectum to allow direct visual examination or to facilitate therapeutic procedures. It is classified as FDA Class 1, the lowest risk tier, subject to general controls only. The product code is FFQ, regulated under 21 CFR 876.4730, within the Gastroenterology, Urology medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    105
    Registration Numbers
    105
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    FFQ
    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

    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
    K851797 53-100 TO 53-120 VARIOUS RECTAL SPECULA(SIMS, MATH

    FEI Numbers

    This FDA classification entry is associated with 105 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 105 registration numbers. Click on an entry to view related FDA registrations.