QWP · Optical Neurosurgical Nerve Locator
Ear, Nose, Throat · 21 CFR 874.1820 · Class 2
Overview
| Product Code | QWP |
|---|---|
| Device Name | Optical Neurosurgical Nerve Locator |
| Regulation | 21 CFR 874.1820 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
Identification
A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K222106 | Waypoint GPS | Waypoint Orthopedics, Inc. | May 12, 2023 | SESE |
Top Applicants
- Waypoint Orthopedics, Inc. — 1 clearance
