Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)— 510(k) K253098

Substantially Equivalent

Nexstim Oyj

FDA 510(k) clearance K253098 for Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6), Substantially Equivalent on 2026-03-20. Applicant: Nexstim Oyj.

Clearance details

Applicant: Nexstim Oyj
Product code: Code OBP
Advisory panel: Neurology
Date received: 2025-09-23
Decision date: 2026-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

Adverse events under product code OBP

product code OBP

Injury: 270
Total: 270

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.