Submission Details
| 510(k) Number | K232415 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Nalu Neurostimulation System for Peripheral Nerve Stimulation
Aug 2024
Decision
376d
Days
Class 2
Risk
About This 510(k) Submission
K232415 is an FDA 510(k) clearance for the Nalu Neurostimulation System for Peripheral Nerve Stimulation, 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 review panel. Regulated under 21 CFR 882.5870.
Device Classification
| Product Code | GZF — Stimulator, Peripheral Nerve, Implanted (pain Relief) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.5870 |
Manufacturer
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