ClearanceBrief
Panels › Gastroenterology, Urology › Product code QFQ · Class 2

Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss

Regulation 876.5982

1510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in QFQ

Company510(k)sRecalls
Gelesis SRL30
Epitomee Medical , Ltd.10
Decided510(k)Device and applicantCode
Oct 2, 2026K261783Plenity-V (MC0979 / GS110)
Gelesis SRL, IT
QFQ
Sep 13, 2024K240544Epitomee
Epitomee Medical , Ltd., IL
QFQ
Jan 19, 2024K230133Plenity
Gelesis, Inc.
QFQ
Apr 12, 2019DEN180060Plenity
Gelesis, Inc.
QFQ

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