K220160 is an FDA 510(k) clearance for the PediGuard Threaded. This device is classified as a Neurosurgical Nerve Locator (Class II - Special Controls, product code PDQ).
Submitted by Spineguard S.A. (Vincennes, FR). The FDA issued a Cleared decision on March 31, 2022, 71 days after receiving the submission on January 19, 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 | K220160 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 2022 |
| Decision Date | March 31, 2022 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | PDQ - 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. |