Plenity-V (MC0979 / GS110)— 510(k) K261783
Substantially EquivalentGelesis SRL
FDA 510(k) clearance K261783 for Plenity-V (MC0979 / GS110), Substantially Equivalent on 2026-10-02. Applicant: Gelesis SRL. Device class: 2.
Clearance details
- Applicant
- Gelesis SRL
- Product code
- Code QFQ
- Device class
- Class 2
- Regulation
- 21 CFR 876.5982
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Calimera, IT
Recent devices under product code QFQ
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