K221303 is an FDA 510(k) clearance for the Neuspera Nuity System. This device is classified as a Stimulator, Peripheral Nerve, Implanted (pain Relief) (Class II - Special Controls, product code GZF).
Submitted by Neuspera Medical, Inc. (San Jose, US). The FDA issued a Cleared decision on April 11, 2023, 341 days after receiving the submission on May 5, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5870.
| 510(k) Number | K221303 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2022 |
| Decision Date | April 11, 2023 |
| Days to Decision | 341 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZF - Stimulator, Peripheral Nerve, Implanted (pain Relief) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5870 |