Cleared Special

K051384 - MODIFICATION TO: NUVASIVE NEUROVISION J...

K051384 is the FDA 510(k) clearance for MODIFICATION TO: NUVASIVE NEUROVISION J... by Nuvasive, Inc.. It is a Class 2 Neurology device (product code GWF) cleared through the Special 510(k) pathway after a 45-day FDA review.

K051384 · Nuvasive, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
45d
Days
Class 2
Risk

K051384 is an FDA 510(k) clearance for the MODIFICATION TO: NUVASIVE NEUROVISION JJB 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 July 11, 2005 after a review of 45 days - a notably fast clearance cycle.

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. 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 Nuvasive, Inc. devices

Submission Details

510(k) Number K051384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2005
Decision Date July 11, 2005
Days to Decision 45 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
103d faster than avg
Panel avg: 148d · This submission: 45d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 50
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K051384.
NEUROVISION JJB SYSTEM
K072343 · Nuvasive, Inc. · Oct 2007
MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM
K062765 · Nuvasive, Inc. · Jan 2007
MEE-1000A NEUROMASTER
K051178 · Nihon Kohden America, Inc. · Aug 2005
TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR
K042350 · Cadwell Laboratories, Inc. · Nov 2004
XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248
K040358 · Excel Tech. , Ltd. · Aug 2004
XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)
K010092 · Excel Tech. , Ltd. · Apr 2001