Cleared Traditional

K051718 - NUVASIVE NEUROVISION JJB SYSTEM

K051718 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 80-day FDA review.

K051718 · Nuvasive, Inc. · Ear, Nose, Throat device
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Sep 2005
Decision
80d
Days
Class 2
Risk

K051718 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 September 15, 2005 after a review of 80 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nuvasive, Inc. devices

Submission Details

510(k) Number K051718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2005
Decision Date September 15, 2005
Days to Decision 80 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
9d faster than avg
Panel avg: 89d · This submission: 80d
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 K051718.
DISPOSABLE STIMULATING ELECTRODE
K111597 · Nuvasive, Inc. · Oct 2011
STIMULATING BUR GUARD
K063305 · Medtronic Xomed, Inc. · Nov 2006
XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238
K062549 · Excel Tech. , Ltd. · Oct 2006
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE
K050162 · Medtronic Xomed, Inc. · Mar 2005
NUVASIVE NEUROVISION JJB SYSTEM
K040543 · Nuvasive, Inc. · Apr 2004
NUVASIVE NEUROVISION JJB SYSTEM
K032083 · Nuvasive, Inc. · Oct 2003