Cleared Special

K094054 - MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE

K094054 is an FDA 510(k) clearance for MODIFCATION TO: NUVASIVE NEUROVISION EM..., manufactured by Nuvasive, Inc.. The device is a Class 2 Neurology device with product code GWF cleared through the Special 510(k) pathway after a 134-day FDA review.

K094054 · Nuvasive, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
134d
Days
Class 2
Risk

K094054 is an FDA 510(k) clearance for the MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on May 14, 2010 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - the FDA neurology 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nuvasive, Inc. devices

FDA 510(k) Submission Details - K094054

510(k) Number K094054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2009
Decision Date May 14, 2010
Days to Decision 134 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 148d · This submission: 134d
Pathway characteristics
Modification to existing cleared device.

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 96
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K094054.
CAREFUSION NICOLET EDX
K112052 · Carefusion 209, Inc. · Mar 2012
C2 NERVEMONITOR SYSTEM WITH ACCESSORIES
K111647 · Inomed Medizintechnik GmbH · Oct 2011
NEUROVISION NERVE LOCATOR MONITOR
K110140 · Neurovision Medical Products, Inc. · Sep 2011
MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION
K091940 · Tonica Elektronik A/S · Mar 2010
NUVASIVE NEURO VISION SYSTEM
K090298 · Nuvasive, Inc. · Jun 2009
NIM 3.0
K083124 · Medtronic Xomed, Inc. · Feb 2009