# Gelesis, Inc.

- Location (FDA's records): Boston, MA
- FDA decisions: 3 (2019–2026): 2 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Gelesis, Inc. (2); Gelesis SRL (1)
- Product codes: QFQ (3)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Epitomee Medical, Ltd.: 1 (https://510kreport.com/company/epitomee-medical)

## Its most-cited devices
- DEN180060: Plenity (2019), cited by 2

## Recent decisions
- K261783: Plenity-V (MC0979 / GS110) (Oct 2, 2026)
- K230133: Plenity (Jan 19, 2024)
- DEN180060: Plenity (Apr 12, 2019)

Source page: https://510kreport.com/company/gelesis