Cleared Traditional

K123843 - NEUROEPG SYSTEM

K123843 is an FDA 510(k) clearance for NEUROEPG SYSTEM, manufactured by Strohl Medical Technologies. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K123843 · Strohl Medical Technologies · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
174d
Days
Class 2
Risk

K123843 is an FDA 510(k) clearance for the NEUROEPG SYSTEM. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Strohl Medical Technologies (Kittery, US). The FDA issued a Cleared decision on June 5, 2013 after a review of 174 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.

FDA 510(k) Submission Details - K123843

510(k) Number K123843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2012
Decision Date June 05, 2013
Days to Decision 174 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 149d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 123
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K123843.
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K120397 · Nihon Kohden Corp. · Sep 2012
NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
K112881 · Nexstim OY · May 2012
K123843 · NEUROEPG SYSTEM
Download PDF FDA Summary Strohl Medical Techno…