QWP · Class II · 21 CFR 874.1820

FDA Product Code QWP: Optical Neurosurgical Nerve Locator

To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery.

Leading manufacturers include Waypoint Orthopedics, Inc..

1
Total
1
Cleared
298d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Optical Neurosurgical Nerve Locator Devices (Product Code QWP)

1 devices
1–1 of 1

About Product Code QWP - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QWP since 2023, with 1 receiving FDA clearance (average review time: 298 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QWP devices are reviewed by the Neurology panel. Browse all Neurology devices →