BEUDAMED
    Product Code: PGU FDA class 2 21 CFR 876.1500

    Spatial Imaging For Display Of Endoscope Position

    Gastroenterology, Urology

    The Spatial Imaging Device for Display of Endoscope Position is a gastrointestinal imaging aid that detects and displays the real-time shape and position of an inserted endoscope, helping clinicians navigate the instrument during procedures. It is an FDA Class 2 device regulated under 21 CFR 876.1500, requiring 510(k) clearance, within the Gastroenterology and Urology (GU) medical specialty. The product code is PGU. This device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    1
    Years Active
    —

    Basic Information

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

    Device Characteristics

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

    Definition

    To detect and display the shape of an inserted endoscope.

    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
    K134026 ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.