BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)

    K Number: K261369 · Decision May 29, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    19
    Applicant Total
    6
    Review Days
    32

    Basic Information

    Device Name
    GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)
    K Number
    K261369
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1520
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cosmo Artificial Intelligence - Ai, Ltd.
    Date Received
    April 27, 2026
    Decision Date
    May 29, 2026
    Product Code
    QNP
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QNP Gastrointesinal Lesion Software Detection System

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    Other Clearances by Cosmo Artificial Intelligence - Ai, Ltd.

    K Number Device Name
    K241887 GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)
    K233964 GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)
    K231143 GI Genius System 100 and GI Genius System 200
    K211951 GI Genius
    DEN200055 GI Genius