BEUDAMED
    Product Code: FCQ FDA class 2 21 CFR 876.1500

    Light Source, Incandescent, Diagnostic

    Gastroenterology, Urology

    The Incandescent Diagnostic Light Source (product code FCQ) is an illumination device using an incandescent bulb to provide light for endoscopic examination and diagnosis. It is an FDA Class 2 device (moderate risk), subject to general controls with no 510(k) required under the applicable submission type. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. No special flags apply.

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

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    Basic Information

    Product Code
    FCQ
    Device Class
    FDA class 2
    Regulation Number
    876.1500
    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
    K960081 BATTERY POWERED ENDOSCCOPIC LIGHT SOURCE

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.