BEUDAMED
    Product Code: FEJ FDA class 1 21 CFR 876.1500

    Attachment, Binocular, For Endoscope

    Gastroenterology, Urology

    The Binocular Attachment for Endoscope is an optical accessory that attaches to an endoscope to allow simultaneous viewing by two observers during gastrointestinal or urological procedures. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, with no requirement for 510(k) premarket notification. The product code is FEJ, regulated under 21 CFR 876.1500, within the Gastroenterology, Urology medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    FEJ
    Device Class
    FDA class 1
    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
    K840837 TBI TRAINER