Cleared Traditional

K112881 - NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)

K112881 is an FDA 510(k) clearance for NEXSTIM NAVIGATED BRAIN STIMULATION (NB..., manufactured by Nexstim OY. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K112881 · Nexstim OY · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
235d
Days
Class 2
Risk

K112881 is an FDA 510(k) clearance for the NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH.... Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Nexstim OY (Helsinki, FI). The FDA issued a Cleared decision on May 22, 2012 after a review of 235 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nexstim OY devices

FDA 510(k) Submission Details - K112881

510(k) Number K112881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2011
Decision Date May 22, 2012
Days to Decision 235 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 148d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWF Device Classification - Class 2, Special Controls

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 69
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