K232415 is an FDA 510(k) clearance for the Nalu Neurostimulation System for Peripheral Nerve Stimulation. This device is classified as a Stimulator, Peripheral Nerve, Implanted (pain Relief) (Class II - Special Controls, product code GZF).
Submitted by Boston Scientific Neuromodulation (Valencia, US). The FDA issued a Cleared decision on August 21, 2024, 376 days after receiving the submission on August 11, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5870.
| 510(k) Number | K232415 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2023 |
| Decision Date | August 21, 2024 |
| Days to Decision | 376 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 |