Cleared Abbreviated

NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM (K091457) - FDA 510(k) Clearance

Class II Neurology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K091457 · Nexstim OY · Neurology device
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Dec 2009
Decision
204d
Days
Class 2
Risk

K091457 is an FDA 510(k) clearance for the NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Nexstim OY (North Attleboro, US). The FDA issued a Cleared decision on December 8, 2009 after a review of 204 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - the FDA neurology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Nexstim OY devices

Submission Details

510(k) Number K091457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2009
Decision Date December 08, 2009
Days to Decision 204 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 148d · This submission: 204d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWF Stimulator, Electrical, Evoked Response

All 138
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