510(k) K222106
K222106 is an FDA 510(k) premarket notification submitted by Waypoint Orthopedics, Inc. for the device "Waypoint GPS". The FDA issued a decision of Substantially Equivalent on May 12, 2023. The device falls under product code QWP (Optical Neurosurgical Nerve Locator), a Class II device regulated under 21 CFR 874.1820.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 2023
- Date Received
- July 18, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Optical Neurosurgical Nerve Locator
- Device Class
- Class II
- Regulation Number
- 874.1820
- Review Panel
- NE
- Submission Type
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.