Cleared Special

K040543 - NUVASIVE NEUROVISION JJB SYSTEM

K040543 is the FDA 510(k) clearance for NUVASIVE NEUROVISION JJB SYSTEM by Nuvasive, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ETN) cleared through the Special 510(k) pathway after a 30-day FDA review.

K040543 · Nuvasive, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
30d
Days
Class 2
Risk

K040543 is an FDA 510(k) clearance for the NUVASIVE NEUROVISION JJB SYSTEM. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on April 1, 2004 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1820 - the FDA ear, nose and throat 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 K040543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2004
Decision Date April 01, 2004
Days to Decision 30 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 89d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ETN Stimulator, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETN Stimulator, Nerve

All 37
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K040543.
XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238
K062549 · Excel Tech. , Ltd. · Oct 2006
NUVASIVE NEUROVISION JJB SYSTEM
K051718 · Nuvasive, Inc. · Sep 2005
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE
K050162 · Medtronic Xomed, Inc. · Mar 2005
NUVASIVE NEUROVISION JJB SYSTEM
K032083 · Nuvasive, Inc. · Oct 2003
STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES
K031003 · Medtronic Xomed, Inc. · Apr 2003
STIMULUS - DISSECTION INSTRUMENTS
K014165 · Medtronic Xomed, Inc. · Jan 2002