Product code
FET: Endoscopic video imaging system/component, gastroenterology-urology
FDA product code · Class II · Gastroenterology/Urology
Key facts
| Product code | FET |
|---|---|
| Device | Endoscopic video imaging system/component, gastroenterology-urology |
| Device class | Class II |
| Regulation number | 876.1500 |
| 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 | To allow for visualization of body cavities through an endoscope by projecting images to a monitor. |
At a glance
- 100–999 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 100–999 UDI devices (GUDID)
- 1,000+ MAUDE adverse event reports
- 1–9 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