BEUDAMED
    Product Code: NEJ FDA class 2 21 CFR 878.4350

    System, Cryosurgical, Liquid Nitrogen, For Gastroenterology

    General, Plastic Surgery

    The System, Cryosurgical, Liquid Nitrogen, For Gastroenterology (product code NEJ) is a device that uses liquid nitrogen to deliver cryotherapy within the gastrointestinal tract, used for ablation of abnormal tissue such as Barrett's esophagus, dysplasia, or early cancers. It is classified as an FDA Class 2 device within the General and Plastic Surgery specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

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

    Product Code
    NEJ
    Device Class
    FDA class 2
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

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