Cleared Special

K053141 - NEUROSIGN MOTOR NERVE MONITOR

K053141 is an FDA 510(k) clearance for NEUROSIGN MOTOR NERVE MONITOR, manufactured by The Magstim Company , Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Special 510(k) pathway after a 35-day FDA review.

K053141 · The Magstim Company , Ltd. · Ear, Nose, Throat device
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Dec 2005
Decision
35d
Days
Class 2
Risk

K053141 is an FDA 510(k) clearance for the NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by The Magstim Company , Ltd. (Whitland, Dyfed Wales, GB). The FDA issued a Cleared decision on December 14, 2005 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1820 - the FDA ear, nose and throat device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all The Magstim Company , Ltd. devices

FDA 510(k) Submission Details - K053141

510(k) Number K053141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2005
Decision Date December 14, 2005
Days to Decision 35 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 89d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

ETN Device Classification - Class 2, Special Controls

Product Code ETN Stimulator, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETN Stimulator, Nerve

All 43
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K053141.
DISPOSABLE STIMULATING ELECTRODE
K111597 · Nuvasive, Inc. · Oct 2011
STIMULATING BUR GUARD
K063305 · Medtronic Xomed, Inc. · Nov 2006
XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238
K062549 · Excel Tech. , Ltd. · Oct 2006
NUVASIVE NEUROVISION JJB SYSTEM
K051718 · Nuvasive, Inc. · Sep 2005
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE
K050162 · Medtronic Xomed, Inc. · Mar 2005
NUVASIVE NEUROVISION JJB SYSTEM
K040543 · Nuvasive, Inc. · Apr 2004