Cleared Traditional

K110419 - AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS

K110419 is an FDA 510(k) clearance for AVS ARIA NEUROMONITORING PROBE AND AVS ..., manufactured by Stryker Spine. The device is a Class 2 Neurology device with product code GXZ cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K110419 · Stryker Spine · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
164d
Days
Class 2
Risk

K110419 is an FDA 510(k) clearance for the AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on July 28, 2011 after a review of 164 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1350 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Spine devices

FDA 510(k) Submission Details - K110419

510(k) Number K110419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2011
Decision Date July 28, 2011
Days to Decision 164 days
Submission Type Traditional
Review Panel Neurology (NE)
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: 148d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXZ Device Classification - Class 2, Special Controls

Product Code GXZ Electrode, Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1350
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 Neurology devices follow this clearance model.

Regulatory Peers - GXZ Electrode, Needle

All 29
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K110419.
MR CONDITIONAL PRESSON ELECTRODE
K130220 · Rhythmlink International, LLC · Jul 2013
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,
K130136 · Technomed Europe · Jul 2013
PRESSON ELECTRODE
K121347 · Rhythmlink International, LLC · Jul 2012
DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
K100912 · Kirwan Surgical Products, Inc. · Aug 2010
NERVE MONITORING CABLE
K073229 · Pioneer Surgical Technology · Jun 2008
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
K071185 · Ambu A/S · May 2007