BEUDAMED
    Product Code: QGY FDA class 2 21 CFR 876.1500

    Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera

    Gastroenterology, Urology

    The Mobile/Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera is a software device intended for wireless control of settings for a surgical or endoscopic camera control unit and patient information system, enabling hands-free or remote adjustment during procedures. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 876.1500 in the Gastroenterology and Urology specialty. The product code is QGY. It is not an implant and is not life-sustaining.

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

    Basic Information

    Product Code
    QGY
    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

    Device is intended for wireless control of settings for surgical or endoscopic camera control unit and patient information system.

    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
    K190367 Smith & Nephew Tablet Application

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.