FDA Product Code
FDA Product Code QFQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5982
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261783 | Plenity-V (MC0979 / GS110) | Gelesis SRL | 2026-10-02 | Traditional | PDF ↗ |
| K240544 | Epitomee | Epitomee Medical , Ltd. | 2024-09-13 | Traditional | PDF ↗ |
| K230133 | Plenity | Gelesis, Inc. | 2024-01-19 | Traditional | PDF ↗ |
| DEN180060 | Plenity | Gelesis, Inc. | 2019-04-12 | Direct | — |
Product code QFQ · Class II · Gastroenterology, Urology. Data: openFDA.