Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation (K233801)
Description
Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation by Nalu Medical, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233801
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation (K233801) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221376 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | 2022 |
| K202274 | Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual ... | Boston Scientific Neuromodulation | 2020 |
| K183579 | Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual... | Boston Scientific Neuromodulation | 2019 |
Trace the full predicate network for K233801
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.