BEUDAMED
    Product Code: FCZ FDA class 1 21 CFR 876.1500

    Tube, Smoke Removal, Endoscopic

    Gastroenterology, Urology

    The Endoscopic Smoke Removal Tube (product code FCZ) is a suction tube accessory used during endoscopic procedures to evacuate surgical smoke or gas from the operative field, maintaining clear visualization. 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
    51
    Registration Numbers
    51
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    FCZ
    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 51 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 51 registration numbers. Click on an entry to view related FDA registrations.