QWP — Optical Neurosurgical Nerve Locator Class II
FDA product code QWP covers "Optical Neurosurgical Nerve Locator", a Class II medical device regulated under 21 CFR 874.1820. Submissions are reviewed by the Ear, Nose, Throat panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QWP
- Device Class
- Class II
- Regulation Number
- 874.1820
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Definition
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K222106 | waypoint orthopedics | Waypoint GPS | May 12, 2023 |