Nexstim Navigated Brain Therapy (NBT) System 2— 510(k) K182700

Name: FDA 510(k) clearance K182700
Creator: U.S. Food and Drug Administration
Published: 2019-03-22

Substantially Equivalent

Nexstim Plc

FDA 510(k) clearance K182700 for Nexstim Navigated Brain Therapy (NBT) System 2, Substantially Equivalent on 2019-03-22. Applicant: Nexstim Plc. Device class: 2.

Clearance details

Applicant: Nexstim Plc
Product code: Code OBP
Device class: Class 2
Regulation: 21 CFR 882.5805
Advisory panel: Neurology
Date received: 2018-09-27
Decision date: 2019-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

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K171902 — Nexstim Navigated Brain Therapy (NBT) System 22017-11-10

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.