510(k) K183579 ยท GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits
| Applicant | Boston Scientific Neuromodulation, Valencia CA, US |
| Decision | Substantially Equivalent, Mar 29, 2019 |
| Received | Dec 21, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183579
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2024 | Nalu Medical, Inc. Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US
Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US
Components of the Nalu Spinal Cord Stimulation System. Open, Classified |
GZF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.