BEUDAMED
    Product Code: SFE FDA class 2 21 CFR 876.1500

    Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation

    Gastroenterology, Urology

    An endoscopic video imaging system or software component for real-time video augmentation is a gastroenterology device that allows visualization of body cavities through an endoscope with real-time software augmentation of video images displayed on a monitor, enhancing endoscopic imaging for improved procedural visualization and clinical decision support. It is classified as FDA Class II (510(k) required) under regulation 876.1500 in the Gastroenterology and Urology specialty, reviewed by the Surgery panel, with product code SFE. The device is not an implant and does not support life-sustaining functions.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    1

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    Basic Information

    Product Code
    SFE
    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

    Definition

    To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K253984 Instrument Exit Point on Touch Surgery™ Aide
    K250268 HyperSnap Surgical System (HSS)