Plenity— 510(k) K230133
Substantially EquivalentGelesis, Inc.
FDA 510(k) clearance K230133 for Plenity, Substantially Equivalent on 2024-01-19. Applicant: Gelesis, Inc.. Device class: 2.
Clearance details
- Applicant
- Gelesis, Inc.
- 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
- Boston, MA, US
Recent devices under product code QFQ
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