QFQ
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5982
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.
- Adverse events (MAUDE)
- 2022: 24
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Epitomee (K240544) | Epitomee Medical , Ltd. | 2024-09-13 |
| Plenity (K230133) | Gelesis, Inc. | 2024-01-19 |
| Plenity (DEN180060) | Gelesis, Inc. | 2019-04-12 |
Track QFQ automatically
Every clearance here is in the API, with alerts when new ones post.