K230133
- 510(k) number
- K230133
- Device name
- Plenity
- Applicant
- Gelesis, Inc. MA · US
- Product code
- QFQ — Ingested, Transient, Space Occupying Device For Weig
- Decision date
- 2024-01-19
- Date received
- 2023-01-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K230133.pdf
Official FDA record: K230133
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.