K222106 is an FDA 510(k) clearance for the Waypoint GPS. This device is classified as a Optical Neurosurgical Nerve Locator (Class II - Special Controls, product code QWP).
Submitted by Waypoint Orthopedics, Inc. (Malvern, US). The FDA issued a Cleared decision on May 12, 2023, 298 days after receiving the submission on July 18, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 874.1820. To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery..
| 510(k) Number | K222106 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2022 |
| Decision Date | May 12, 2023 |
| Days to Decision | 298 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | QWP - Optical Neurosurgical Nerve Locator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1820 |
| Definition | To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery. |