# K203547: Nalu Neurostimulation System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Neuromodulation
- Decided: Mar 25, 2021 after 111 days
- Product code: GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5880
- 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). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201618: Nalu Neurostimulation SCS system, Boston Scientific Neuromodulation (2020) Summary page 5.

## Most influential descendants
- K221376: Nalu Neurostimulation System (2022), 1 descendant of its own
- K233801: Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation (2024), 0 descendants of its own

## Indications for use
For Spinal Cord Stimulation This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. 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. For Peripheral Nerve Stimulation 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 day) to determine efficacy before recommendation for a permanent (long term) device.

Source page: https://510kreport.com/device/K203547
Methodology: https://510kreport.com/methodology