Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation

K-Number: K233801 · 2024-08-23

ApplicantBoston Scientific Neuromodulation
Decision Date2024-08-23
Product CodeGZB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation is a medical device manufactured by Boston Scientific Neuromodulation. It received FDA 510(k) clearance on 2024-08-23 under approval number K233801. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation?

Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation is a medical device that received FDA 510(k) clearance on 2024-08-23. It is manufactured by Boston Scientific Neuromodulation. The 510(k) number is K233801.

When was Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation approved by the FDA?

Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation received FDA 510(k) clearance on 2024-08-23, under approval number K233801.

What company makes Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation?

Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation is manufactured by Boston Scientific Neuromodulation.

What is the FDA product code for Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation?

The FDA product code for Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation is GZB.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT04935697 Non-invasive Vagal Neurostimulation (nVNS) for Traumatic Brain Injury (TBI)-Induced Acute Respiratory Distress COMPLETED NCT06577454 Measuring the Effects of Neurostimulation on Risky and Ambiguous Decision-Making Capacity in People With and Without Substance Use Disorder SUSPENDED NCT07517172 Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING

Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 41470022 Low-intensity pulsed ultrasound for peripheral nerve regeneration: mechanobiological mechanisms and translational potential. Journal of translational medicine (2025) PMID: 40077817 Research Progress on Neural Cell Culture Systems. Current neuropharmacology (2025) PMID: 40003250 Bridging the Gap in FDA Approval for Pediatric Neuromodulation Devices. Children (Basel, Switzerland) (2025)

Other Devices by Boston Scientific Neuromodulation

K190960Nalu Lead Blank (50cm) K183579Nalu 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 K183047Nalu Neurostimulation System K202274Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits K201618Nalu Neurostimulation SCS system K203547Nalu Neurostimulation System

View all 10 devices →

Related Devices (Code: GZB)

K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitStimwave Technologies Incorporated K160600Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated K172644Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading BaseStimwave Technologies Incorporated K170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitStimwave Technologies Incorporated K180981Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitStimwave Technologies Incorporated K191466SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑