QFQ
- Product code
- QFQ
- Device name
- Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5982
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 3 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K240544 | 2024-09-13 | Epitomee Medical , Ltd. | Epitomee | |
| K230133 | 2024-01-19 | Gelesis, Inc. | Plenity |
Official FDA classification page: QFQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).