Data / Medical devices / Italy / Gelesis SRL
Gelesis SRL: FDA-registered device maker in Calimera Lecce, Italy, 1 510(k) clearance
Gelesis SRL is registered with the FDA (registration 3012121187) in Calimera Lecce, Italy. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 19, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012121187
- Address
- Via Europa, 187, Calimera Lecce, Italy, 73021
- Owner or operator
- Gelesis srl (10060654)
- Roles
- Manufacturer
- First device listed
- February 13, 2024
- Registered through
- 2026
- Brand names listed
- Plenity®
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss | QFQ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 19, 2024 | K230133 | Plenity | QFQ | Substantially Equivalent | Gelesis, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 19, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.