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FDA 510(k)

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

K-Number: K253098 · 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 the device name listed in this FDA 510(k) record. The listed applicant is Nexstim Oyj. It received FDA 510(k) clearance on 2026-03-20 under 510(k) number K253098. 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. The listed applicant is Nexstim Oyj. The 510(k) number is K253098.

When did Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) receive FDA 510(k) clearance?

Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) received FDA 510(k) clearance on 2026-03-20, under 510(k) number K253098.

Who is the listed applicant for Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)?

The FDA 510(k) record lists Nexstim Oyj as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Nexstim Oyj as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)

Related Devices (Code: OBP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261228QuickVision Ultimate rTMSBrain Ultimate, Inc.K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbHK260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/SK252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK251653SPRY TMS Therapy System (0550)Soterix Medical, Inc.K251391BrainsWay Deep TMS SystemBrainsway , Ltd.

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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