Cleared Traditional

K110422 - SURGICAL STIMULATORS

K110422 is an FDA 510(k) clearance for SURGICAL STIMULATORS, manufactured by Technomed Europe. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K110422 · Technomed Europe · Ear, Nose, Throat device
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May 2011
Decision
101d
Days
Class 2
Risk

K110422 is an FDA 510(k) clearance for the SURGICAL STIMULATORS. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Technomed Europe (Maastricht-Airport, NL). The FDA issued a Cleared decision on May 26, 2011 after a review of 101 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 Technomed Europe devices

FDA 510(k) Submission Details - K110422

510(k) Number K110422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2011
Decision Date May 26, 2011
Days to Decision 101 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
11d slower than avg
Panel avg: 90d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 63
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K110422.
RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT
K112435 · Rhythmlink International, LLC · Sep 2011
NEURO CHECK DEVICE WITH IO-FLEX WIRE
K110696 · Baxano, Inc. · Jul 2011
DRYTOUCH SUCTION STIMULATOR PROBE
K110712 · Neurovision Medical Products, Inc. · Jun 2011
PAIRED HYDROGEL ELECTRODE
K110138 · Neurovision Medical Products, Inc. · Apr 2011
RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT
K072736 · Rhythmlink International, LLC · Jan 2008
STIMULATING BUR GUARD
K063305 · Medtronic Xomed, Inc. · Nov 2006