BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Plenity

    K Number: K230133 · Decision Jan 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    367

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    Basic Information

    Device Name
    Plenity
    K Number
    K230133
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5982
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gelesis, Inc.
    Date Received
    January 17, 2023
    Decision Date
    January 19, 2024
    Product Code
    QFQ
    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
    QFQ Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss

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