K203547 is an FDA 510(k) clearance for the Nalu Neurostimulation System. This device is classified as a Stimulator, Spinal-cord, Implanted (pain Relief) (Class II - Special Controls, product code GZB).
Submitted by Boston Scientific Neuromodulation (Valencia, US). The FDA issued a Cleared decision on March 25, 2021, 111 days after receiving the submission on December 4, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5880.
| 510(k) Number | K203547 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2020 |
| Decision Date | March 25, 2021 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZB — Stimulator, Spinal-cord, Implanted (pain Relief) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5880 |