Cleared Special

K991583 - NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR

K991583 is an FDA 510(k) clearance for NEUROSIGN 400, 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 12-day FDA review.

K991583 · The Magstim Company , Ltd. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
12d
Days
Class 2
Risk

K991583 is an FDA 510(k) clearance for the NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by The Magstim Company , Ltd. (New York, US). The FDA issued a Cleared decision on May 19, 1999 after a review of 12 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 - K991583

510(k) Number K991583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1999
Decision Date May 19, 1999
Days to Decision 12 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 90d · This submission: 12d
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 79
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K991583.
LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET
K003745 · Rln Systems, Inc. · Jan 2001
CAVERMAP SURGICAL AID
K000507 · Uromed Corp. · Apr 2000
XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE
K992869 · Xomed, Inc. · Oct 1999
NIM4
K982595 · Xomed, Inc. · Sep 1998
NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR
K980148 · The Magstim Company , Ltd. · Aug 1998
URO MED NERVE STIMULATOR
K970971 · Uromed Corp. · Oct 1997