BEUDAMED
    Product Code: NYV FDA class 2 21 CFR 876.1725

    Gastrointestinal Motility System, Capsule

    Gastroenterology, Urology

    The Gastrointestinal Motility System, Capsule (product code NYV) is an ingestible capsule-based diagnostic system used to evaluate gastrointestinal motility disorders by measuring transit times and other physiological parameters throughout the GI tract, indicated for patients with suspected motility disorders. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 876.1725 within the Gastroenterology and Urology specialty. The device carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    5
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    3
    Years Active
    20

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    Basic Information

    Product Code
    NYV
    Device Class
    FDA class 2
    Regulation Number
    876.1725
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

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

    Definition

    Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 5 510(k) clearances via K numbers.

    K Number Device Name
    K253569 Atmo Gas Capsule System
    K250940 Atmo Gas Capsule System
    K250493 MotiliCap GI Monitoring System
    K092342 SMARTPILL GI MONITORING SYSTEM, VERSION 2.0
    K053547 SMARTPILL GI MONITORING SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.