# K232415: Nalu Neurostimulation System for Peripheral Nerve Stimulation

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Neuromodulation
- Decided: Aug 21, 2024 after 376 days
- Product code: GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K883780 (1988). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183579: 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, Boston Scientific Neuromodulation (2019) Summary page 5.

## Indications for use
This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

Source page: https://510kreport.com/device/K232415
Methodology: https://510kreport.com/methodology