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) Official FDA 510(k) Summary (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.

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
15d faster than avg
Panel avg: 149d · 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 140
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K094054 · MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE
Download PDF FDA Summary Nuvasive, Inc.