Cleared Traditional

K140400 - ES2 NEUROMONITORING ACCESSORY INSTRUMENTS

K140400 is the FDA 510(k) clearance for ES2 NEUROMONITORING ACCESSORY INSTRUMENTS by Stryker Corporation. It is a Class 2 Ear, Nose, Throat device (product code ETN) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K140400 · Stryker Corporation · Ear, Nose, Throat device
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Jul 2014
Decision
133d
Days
Class 2
Risk

K140400 is an FDA 510(k) clearance for the ES2 NEUROMONITORING ACCESSORY INSTRUMENTS. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Stryker Corporation (Allendale, US). The FDA issued a Cleared decision on July 1, 2014 after a review of 133 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 Stryker Corporation devices

Submission Details

510(k) Number K140400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2014
Decision Date July 01, 2014
Days to Decision 133 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
44d slower than avg
Panel avg: 89d · This submission: 133d
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 26
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K140400.
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
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Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
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StimSite
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NUVASIVE NVJJB SYSTEM
K112717 · Nuvasive, Inc. · Apr 2012
NUVASIVE NVM5 SYSTEM
K112718 · Nuvasive, Inc. · Mar 2012
STIMULATION/DISSECTION INSTRUMENTS
K112709 · Nu Vasive, Incorporated · Feb 2012