K190960 is an FDA 510(k) clearance for the Nalu Lead Blank (50cm). 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 July 11, 2019, 90 days after receiving the submission on April 12, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5880.
| 510(k) Number | K190960 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 2019 |
| Decision Date | July 11, 2019 |
| Days to Decision | 90 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 |