Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)— 510(k) K252358
Substantially EquivalentNexstim Oyj
FDA 510(k) clearance K252358 for Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6), Substantially Equivalent on 2026-03-20. Applicant: Nexstim Oyj. Device class: 2.
Summary
Nexstim Oyj's Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) is filed under OBP, transcranial magnetic stimulators. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 882.5805. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Nexstim filed from Helsinki, Finland. Review took 234 calendar days (July 29, 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.