K211965 is an FDA 510(k) clearance for the StimRouter Neuromodulation System. This device is classified as a Stimulator, Peripheral Nerve, Implanted (pain Relief) (Class II - Special Controls, product code GZF).
Submitted by Bioness, Inc. (Valencia, US). The FDA issued a Cleared decision on February 23, 2022, 244 days after receiving the submission on June 24, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5870.
| 510(k) Number | K211965 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2021 |
| Decision Date | February 23, 2022 |
| Days to Decision | 244 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 |