BEUDAMED
    Product Code: MQW FDA class 1 21 CFR 874.4350

    Transilluminator, Fiber Optic

    Ear, Nose, Throat

    The Fiber Optic Transilluminator is an ear, nose, and throat device that uses fiber optic light transmission to illuminate anatomical structures, such as sinuses or other cavities, for diagnostic visualization during clinical examination. Classified as FDA Class 1 under 21 CFR 874.4350 in the Ear, Nose, Throat specialty, it is 510(k)-exempt and subject only to general controls. The product code is MQW.

    View on FDA
    510(k)s
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Unique Applicants
    1
    Years Active
    —

    Research product code MQW 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
    MQW
    Device Class
    FDA class 1
    Regulation Number
    874.4350
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K962032 KARL STORZ TWIN TRANSILLUMINATOR

    FEI Numbers

    This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.