BEUDAMED
    Product Code: FBS FDA class 1 21 CFR 876.4590

    Sound, Metal, Interconnected

    Gastroenterology, Urology

    The Interconnected Metal Sound (product code FBS) is a series of linked metal dilating instruments used to assess and progressively dilate the urethra or other body channels in urological procedures. It is an FDA Class 1 device (lowest risk), subject only to general controls with no premarket notification required. It is regulated under 21 CFR 876.4590 in the Gastroenterology and Urology specialty. No special flags apply.

    View on FDA
    510(k)s
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    FBS
    Device Class
    FDA class 1
    Regulation Number
    876.4590
    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
    K954972 LYELL SOUND

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.