Product code
QON: Implanted electrical device intended for treatment of fecal incontinence
FDA product code · Class III · Gastroenterology/Urology
Key facts
| Product code | QON |
|---|---|
| Device | Implanted electrical device intended for treatment of fecal incontinence |
| Device class | Class III |
| Regulation number | 876.5270 |
| Review panel | Gastroenterology/Urology |
| Medical specialty | Gastroenterology/Urology |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | Treatment of chronic fecal incontinence |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- 10–99 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