Nalu Neurostimulation System for Peripheral Nerve Stimulation— 510(k) K232415
Substantially EquivalentBoston Scientific Neuromodulation
FDA 510(k) clearance K232415 for Nalu Neurostimulation System for Peripheral Nerve Stimulation, Substantially Equivalent on 2024-08-21. Applicant: Boston Scientific Neuromodulation.
Clearance details
- Applicant
- Boston Scientific Neuromodulation
- Product code
- Code GZF
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Valencia, CA, US
Adverse events under product code GZF
product code GZF- Death
- 10
- Injury
- 2,410
- Other
- 1
- Total
- 2,421
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.