K233801
- 510(k) number
- K233801
- Device name
- Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
- Applicant
- Boston Scientific Neuromodulation CA · US
- Product code
- GZB — Stimulator, Spinal-Cord, Implanted (Pain Relief)
- Decision date
- 2024-08-23
- Date received
- 2023-11-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233801.pdf
Official FDA record: K233801
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.