Cleared Traditional

K111597 - DISPOSABLE STIMULATING ELECTRODE

K111597 is an FDA 510(k) clearance for DISPOSABLE STIMULATING ELECTRODE, manufactured by Nuvasive, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K111597 · Nuvasive, Inc. · Ear, Nose, Throat device
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Oct 2011
Decision
127d
Days
Class 2
Risk

K111597 is an FDA 510(k) clearance for the DISPOSABLE STIMULATING ELECTRODE. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on October 13, 2011 after a review of 127 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 Nuvasive, Inc. devices

FDA 510(k) Submission Details - K111597

510(k) Number K111597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2011
Decision Date October 13, 2011
Days to Decision 127 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
37d slower than avg
Panel avg: 90d · This submission: 127d
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 61
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K111597.
STIMULATION/DISSECTION INSTRUMENTS
K112709 · Nu Vasive, Incorporated · Feb 2012
SEASPINE MONOPOLAR PROBE SYSYEM
K111671 · Seaspine, Inc. · Dec 2011
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
K110989 · Neurovision Medical Products, Inc. · Nov 2011
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