510(k) K261783 ยท QFQ Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
Plenity-V (MC0979 / GS110)
| Applicant | Gelesis SRL, Calimera, IT |
| Decision | Substantially Equivalent, Oct 2, 2026 |
| Received | May 29, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261783
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.