BEUDAMED
    Product Code: FDY FDA class 1 21 CFR 876.1500

    Device, Measuring, For Panendoscope

    Gastroenterology, Urology

    The Measuring Device for Panendoscope (product code FDY) is an accessory used in conjunction with a panendoscope to measure the size of lesions, strictures, or anatomical structures observed during endoscopic examination. 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 876.1500 in the Gastroenterology and Urology specialty. No special flags apply.

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    510(k)s
    0
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    FDY
    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

    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.