Product code
QGY: Mobile / tablet software application to control settings of surgical and endoscopic camera
FDA product code · Class II · General & Plastic Surgery
Key facts
| Product code | QGY |
|---|---|
| Device | Mobile / tablet software application to control settings of surgical and endoscopic camera |
| Device class | Class II |
| Regulation number | 876.1500 |
| Review panel | General & Plastic Surgery |
| Medical specialty | Gastroenterology/Urology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Device is intended for wireless control of settings for surgical or endoscopic camera control unit and patient information system. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None 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