Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)— 510(k) K253098
Substantially EquivalentNexstim Oyj
FDA 510(k) clearance K253098 for Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6), Substantially Equivalent on 2026-03-20. Applicant: Nexstim Oyj. Device class: 2.
Summary
This Nexstim Oyj record is for the Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6), filed under OBP, transcranial magnetic stimulators. It doesn't describe the system beyond that name and code name.
Class II, 21 CFR 882.5805. It was a Traditional 510(k), and Neurology is both the classification panel and the review panel.
Nexstim filed from Helsinki, Finland. The decision came 178 calendar days after FDA received it (September 23, 2025 to March 20, 2026).
Clearance details
- Applicant
- Nexstim Oyj
- Product code
- Product code OBP
- Device class
- Class 2
- Regulation
- 21 CFR 882.5805
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Helsinki, FI
Recent devices under product code OBP
view allMore clearances from Nexstim Oyj
view allAdverse events under product code OBP
product code OBP- Injury
- 270
- Total
- 270
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.