Product code
ORR: Neurological stereotaxic instrument, real-time intraoperative mri
FDA product code · Class II · Neurology
Key facts
| Product code | ORR |
|---|---|
| Device | Neurological stereotaxic instrument, real-time intraoperative mri |
| Device class | Class II |
| Regulation number | 882.4560 |
| Review panel | Neurology |
| Medical specialty | Neurology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 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