Cleared Special

K062765 - MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM

K062765 is an FDA 510(k) clearance for MODIFICATION TO NUVASIVE NEUROVISION JJ..., 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 117-day FDA review.

K062765 · Nuvasive, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
117d
Days
Class 2
Risk

K062765 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 January 24, 2007 after a review of 117 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 - K062765

510(k) Number K062765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2006
Decision Date January 24, 2007
Days to Decision 117 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
31d faster than avg
Panel avg: 148d · This submission: 117d
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 K062765.
SEN-4100 ELECTRIC STIMULATOR
K071969 · Nihon Kohden America, Inc. · Oct 2008
NEUROVISION JJB SYSTEM
K072343 · Nuvasive, Inc. · Oct 2007
COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65
K071821 · Tonica Elektronik A/S · Jul 2007
MAGPRO, MODEL R30
K061645 · Tonica Elektronik A/S · Oct 2006
MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00
K051864 · The Magstim Company , Ltd. · Dec 2005
DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A
K051357 · Digitimer , Ltd. · Sep 2005