Product code
QFQ: Ingested, transient, space occupying device for weight management and/or weight loss
FDA product code · Class II · Gastroenterology/Urology
Key facts
| Product code | QFQ |
|---|---|
| Device | Ingested, transient, space occupying device for weight management and/or weight loss |
| Device class | Class II |
| Regulation number | 876.5982 |
| Review panel | Gastroenterology/Urology |
| Medical specialty | Gastroenterology/Urology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| 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. |
At a glance
- 1–9 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database