Optical Neurosurgical Nerve Locator
The optical neurosurgical nerve locator (product code QWP) is a Class 2 device in the Ear, Nose, Throat specialty (regulation 874.1820) used to locate or monitor the function of spinal nerve roots or peripheral nerves during neurosurgery. It requires 510(k) clearance and is reviewed by the Neurology panel. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QWP
- Device Class
- FDA class 2
- Regulation Number
- 874.1820
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K222106 | Waypoint GPS | May 12, 2023 | Substantially Equivalent | Waypoint Orthopedics, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.