K221469 is an FDA 510(k) clearance for the PATI (Protector Against Tongue Injury). This device is classified as a Block, Bite (Class II - Special Controls, product code JXL).
Submitted by Neurovice, LLC (Wake Forest, US). The FDA issued a Cleared decision on February 22, 2023, 278 days after receiving the submission on May 20, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5070.
| 510(k) Number | K221469 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2022 |
| Decision Date | February 22, 2023 |
| Days to Decision | 278 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | JXL - Block, Bite |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5070 |