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) Official FDA 510(k) Summary (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.

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
32d faster than avg
Panel avg: 149d · 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 140
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
ECLIPSE TCD NEUROVASCULAR WORKSTATION
K061639 · Axon Systems, Inc. · Nov 2006
MAGPRO, MODEL R30
K061645 · Tonica Elektronik A/S · Oct 2006
MAGSTIM 200-2
K060847 · Magstim Company Us, LLC · Sep 2006
K062765 · MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM
Download PDF FDA Summary Nuvasive, Inc.