Cleared Special

K110138 - PAIRED HYDROGEL ELECTRODE

K110138 is an FDA 510(k) clearance for PAIRED HYDROGEL ELECTRODE, manufactured by Neurovision Medical Products, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Special 510(k) pathway after a 80-day FDA review.

K110138 · Neurovision Medical Products, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
80d
Days
Class 2
Risk

K110138 is an FDA 510(k) clearance for the PAIRED HYDROGEL ELECTRODE. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Neurovision Medical Products, Inc. (Ventura, US). The FDA issued a Cleared decision on April 8, 2011 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. 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.

FDA 510(k) Submission Details - K110138

510(k) Number K110138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2011
Decision Date April 08, 2011
Days to Decision 80 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
10d faster than avg
Panel avg: 90d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

ETN Device Classification - Class 2, Special Controls

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 84
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K110138.
NEURO CHECK DEVICE WITH IO-FLEX WIRE
K110696 · Baxano, Inc. · Jul 2011
DRYTOUCH SUCTION STIMULATOR PROBE
K110712 · Neurovision Medical Products, Inc. · Jun 2011
SURGICAL STIMULATORS
K110422 · Technomed Europe · May 2011
CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,
K103128 · Cadwell Lab, Inc. · Feb 2011
NEUROVISION SE (NERVEANA)
K102862 · Neurovision Medical Products, Inc. · Dec 2010
NEURALMAS
K100992 · Innovative Surgical Solutions, LLC ("Iss") · Sep 2010