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FDA 510(k)

Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)

K-Number: K252358 · 2026-03-20

ApplicantNexstim Oyj
Decision Date2026-03-20
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) is a medical device manufactured by Nexstim Oyj. It received FDA 510(k) clearance on 2026-03-20 under approval number K252358. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)?

Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) is a medical device that received FDA 510(k) clearance on 2026-03-20. It is manufactured by Nexstim Oyj. The 510(k) number is K252358.

When was Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) approved by the FDA?

Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) received FDA 510(k) clearance on 2026-03-20, under approval number K252358.

What company makes Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)?

Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) is manufactured by Nexstim Oyj.

What is the FDA product code for Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)?

The FDA product code for Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) is OBP.

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 NCT06868914 Phase I Trial of High-Density Theta Burst Stimulation (hdTBS) NOT_YET_RECRUITING NCT07615387 Electrophysiological Biomarkers in Accelerated TMS for Depression COMPLETED NCT04935697 Non-invasive Vagal Neurostimulation (nVNS) for Traumatic Brain Injury (TBI)-Induced Acute Respiratory Distress COMPLETED NCT01961557 Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders COMPLETED

Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026)

Other Devices by Nexstim Oyj

K253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)

Related Devices (Code: OBP)

K160309Neurosoft TMSTeleemg, LLC K161519NeuroStar TMS Therapy SystemNeuronetics, Inc. K160703NeuroStar TMS Therapy SystemNeuronetics, Inc. K173441Neurosoft TMS (also CloudTMS)Teleemg, LLC K171902Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc K172667MagVita TMS Therapy w/MagPro R20Tonica Elektronik A/S

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.

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