BEUDAMED
    Product Code: GCW FDA class 2 21 CFR 876.1500

    Transformer, Endoscope

    Gastroenterology, Urology

    The Transformer, Endoscope (product code GCW) is an electrical accessory device that steps down or converts electrical power to the appropriate voltage or current for use with endoscopic equipment, ensuring safe and stable operation during gastroenterological or urological procedures. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. 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
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    GCW
    Device Class
    FDA class 2
    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
    K771864 WALL TRANSFORMERS 74710 & 74910

    FEI Numbers

    This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.