Product code
PDQ: Neurosurgical nerve locator
FDA product code · Class II · Neurology
Key facts
| Product code | PDQ |
|---|---|
| Device | Neurosurgical nerve locator |
| Device class | Class II |
| Regulation number | 874.1820 |
| Review panel | Neurology |
| Medical specialty | Ear Nose & Throat |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery. |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 100–999 UDI devices (GUDID)
- 10–99 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