510(k) K233801 ยท GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
| Applicant | Boston Scientific Neuromodulation, Valencia CA, US |
| Decision | Substantially Equivalent, Aug 23, 2024 |
| Received | Nov 29, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233801
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2026 | Boston Scientific Neuromodulation Corporation Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System Open, Classified |
GZB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.