Nalu Medical, Inc.
FDA Regulatory Profile
Nalu Medical, Inc. appears in FDA public data with 1 recall, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2257-2024, Class II) was initiated on June 3, 2024. Its most recent 510(k) clearance was granted on September 6, 2019.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2257-2024 | Class II | Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Porte | June 3, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K191435 | IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension | September 6, 2019 |