Nexstim Navigated Brain Therapy (NBT) System 2— 510(k) K171902

Substantially Equivalent

Nexstim Plc

FDA 510(k) clearance K171902 for Nexstim Navigated Brain Therapy (NBT) System 2, Substantially Equivalent on 2017-11-10. Applicant: Nexstim Plc.

Clearance details

Applicant: Nexstim Plc
Product code: Code OBP
Advisory panel: Neurology
Date received: 2017-06-26
Decision date: 2017-11-10
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.