Cleared Traditional

K110712 - DRYTOUCH SUCTION STIMULATOR PROBE

K110712 is an FDA 510(k) clearance for DRYTOUCH SUCTION STIMULATOR PROBE, manufactured by Neurovision Medical Products, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K110712 · 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
Jun 2011
Decision
106d
Days
Class 2
Risk

K110712 is an FDA 510(k) clearance for the DRYTOUCH SUCTION STIMULATOR PROBE. 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 June 28, 2011 after a review of 106 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.

FDA 510(k) Submission Details - K110712

510(k) Number K110712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2011
Decision Date June 28, 2011
Days to Decision 106 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
16d slower than avg
Panel avg: 90d · This submission: 106d
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 84
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K110712.
DISPOSABLE STIMULATING ELECTRODE
K111597 · Nuvasive, Inc. · Oct 2011
RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT
K112435 · Rhythmlink International, LLC · Sep 2011
NEURO CHECK DEVICE WITH IO-FLEX WIRE
K110696 · Baxano, Inc. · Jul 2011
SURGICAL STIMULATORS
K110422 · Technomed Europe · May 2011
PAIRED HYDROGEL ELECTRODE
K110138 · Neurovision Medical Products, Inc. · Apr 2011
CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,
K103128 · Cadwell Lab, Inc. · Feb 2011