ORR — Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri Class II
FDA product code ORR covers "Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri", a Class II medical device regulated under 21 CFR 882.4560. Submissions are reviewed by the Neurology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ORR
- Device Class
- Class II
- Regulation Number
- 882.4560
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite.