Product code
QGZ: Electrical tumor treatment fields
FDA product code · Class III · Anesthesiology
Key facts
| Product code | QGZ |
|---|---|
| Device | Electrical tumor treatment fields |
| Device class | Class III |
| Review panel | Anesthesiology |
| Submission type | HDE - Humanitarian Device Exemption |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | Yes |
| Definition | The device is intended to treat patients with inoperable malignant pleural mesothelioma (MPM) concurrent to chemotherapy. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- 1–9 HDE approvals
- 10–99 UDI devices (GUDID)
- 1–9 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