BEUDAMED
    Product Code: GCH FDA class 2 21 CFR 876.1500

    Mediastinoscope, Diagnostic

    Gastroenterology, Urology

    The Mediastinoscope, Diagnostic (product code GCH) is a rigid endoscope introduced through a small incision at the base of the neck to visually examine the mediastinum, the space between the lungs, for diagnostic purposes such as tissue sampling or assessment of lymph nodes. It is classified as FDA Class 2, requiring a 510(k) premarket notification demonstrating substantial equivalence. The device is regulated under 21 CFR 876.1500 in the Gastroenterology, Urology specialty (GU). No special flags apply to this device.

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

    Basic Information

    Product Code
    GCH
    Device Class
    FDA class 2
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

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