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

    Plenity

    K Number: DEN180060 · Decision Apr 12, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    148

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Plenity
    K Number
    DEN180060
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    876.5982
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Gelesis, Inc.
    Date Received
    November 15, 2018
    Decision Date
    April 12, 2019
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QFQ), ordered by most recent decision date.

    Epitomee

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Plenity

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Gelesis, Inc.

    K Number Device Name
    K230133 Plenity