Cleared Traditional

K112709 - STIMULATION/DISSECTION INSTRUMENTS

K112709 is the FDA 510(k) clearance for STIMULATION/DISSECTION INSTRUMENTS by Nu Vasive, Incorporated. It is a Class 2 Ear, Nose, Throat device (product code ETN) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K112709 · Nu Vasive, Incorporated · Ear, Nose, Throat device
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Feb 2012
Decision
143d
Days
Class 2
Risk

K112709 is an FDA 510(k) clearance for the STIMULATION/DISSECTION INSTRUMENTS. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on February 9, 2012 after a review of 143 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 Nu Vasive, Incorporated devices

Submission Details

510(k) Number K112709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2011
Decision Date February 09, 2012
Days to Decision 143 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
54d slower than avg
Panel avg: 89d · This submission: 143d
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 32
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K112709.
ES2 NEUROMONITORING ACCESSORY INSTRUMENTS
K140400 · Stryker Corporation · Jul 2014
NUVASIVE NVJJB SYSTEM
K112717 · Nuvasive, Inc. · Apr 2012
NUVASIVE NVM5 SYSTEM
K112718 · Nuvasive, Inc. · Mar 2012
DISPOSABLE STIMULATING ELECTRODE
K111597 · Nuvasive, Inc. · Oct 2011
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