BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    Atmo Gas Capsule System

    K Number: K253569 · Decision May 22, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    186

    Basic Information

    Device Name
    Atmo Gas Capsule System
    K Number
    K253569
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1725
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Atmo Biosciences, Ltd.
    Date Received
    November 17, 2025
    Decision Date
    May 22, 2026
    Product Code
    NYV
    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
    NYV Gastrointestinal Motility System, Capsule

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    Other Clearances by Atmo Biosciences, Ltd.

    K Number Device Name
    K250940 Atmo Gas Capsule System