510(k) clearance
Plenity-V (MC0979 / GS110)
- 510(k) number
- K261783
- Applicant
- Gelesis SRL
- Decision date
- Oct 2, 2026
- Date received
- May 29, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QFQ
- Device type
- Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
- Device class
- Class II
- Regulation
- 21 CFR 876.5982
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Calimera, IT