Cleared Traditional

K032083 - NUVASIVE NEUROVISION JJB SYSTEM

K032083 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 Traditional 510(k) pathway after a 109-day FDA review.

K032083 · Nuvasive, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
109d
Days
Class 2
Risk

K032083 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 October 24, 2003 after a review of 109 days - within the typical 510(k) review window.

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. 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Nuvasive, Inc. devices

Submission Details

510(k) Number K032083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2003
Decision Date October 24, 2003
Days to Decision 109 days
Submission Type Traditional
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
20d slower than avg
Panel avg: 89d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K032083.
NUVASIVE NEUROVISION JJB SYSTEM
K051718 · Nuvasive, Inc. · Sep 2005
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE
K050162 · Medtronic Xomed, Inc. · Mar 2005
NUVASIVE NEUROVISION JJB SYSTEM
K040543 · Nuvasive, Inc. · Apr 2004
STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES
K031003 · Medtronic Xomed, Inc. · Apr 2003
STIMULUS - DISSECTION INSTRUMENTS
K014165 · Medtronic Xomed, Inc. · Jan 2002
XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE
K992869 · Xomed, Inc. · Oct 1999