Cleared Traditional

K090298 - NUVASIVE NEURO VISION SYSTEM

K090298 is an FDA 510(k) clearance for NUVASIVE NEURO VISION SYSTEM, manufactured by Nuvasive, Inc.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K090298 · Nuvasive, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
122d
Days
Class 2
Risk

K090298 is an FDA 510(k) clearance for the NUVASIVE NEURO VISION SYSTEM. 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 June 8, 2009 after a review of 122 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. 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 - K090298

510(k) Number K090298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2009
Decision Date June 08, 2009
Days to Decision 122 days
Submission Type Traditional
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
27d faster than avg
Panel avg: 149d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K090298.
MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION
K091940 · Tonica Elektronik A/S · Mar 2010
NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)
K083371 · Natus Medical, Inc. · Dec 2009
NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM
K091457 · Nexstim OY · Dec 2009
EVOX ELECTRO DIAGNOSTIC DEVICE
K082614 · Laborie Medical Technologies, Inc. · Mar 2009
NIM 3.0
K083124 · Medtronic Xomed, Inc. · Feb 2009
MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00
K080499 · The Magstim Company , Ltd. · Dec 2008
K090298 · NUVASIVE NEURO VISION SYSTEM
Download PDF FDA Summary Nuvasive, Inc.