Cleared Abbreviated

K053358 - DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES

K053358 is an FDA 510(k) clearance for DEPTH ELECTRODE, manufactured by Ad-Tech Medical Instrument Corp. The device is a Class 2 Neurology device with product code GZL cleared through the Abbreviated 510(k) pathway after a 174-day FDA review.

K053358 · Ad-Tech Medical Instrument Corp · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
174d
Days
Class 2
Risk

K053358 is an FDA 510(k) clearance for the DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECT.... Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Ad-Tech Medical Instrument Corp (Stoughton, US). The FDA issued a Cleared decision on May 25, 2006 after a review of 174 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1330 - the FDA neurology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K053358

510(k) Number K053358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2005
Decision Date May 25, 2006
Days to Decision 174 days
Submission Type Abbreviated
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
25d slower than avg
Panel avg: 149d · This submission: 174d
Pathway characteristics
Standards-based clearance path.

GZL Device Classification - Class 2, Special Controls

Product Code GZL Electrode, Depth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1330
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 - GZL Electrode, Depth

All 55
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K053358.
NEURONAV SYSTEM AND NEURONAV DRIVE
K071697 · Alpha Omega , Ltd. · Dec 2007
NEUROPORT ELECTRODE
K070272 · Cyberkinetics Neurotechnology Systems, Inc. · Aug 2007
MICROTARGETING GUIDELINE 4000
K071364 · FHC, Inc. · Jul 2007
NEUROPROBES
K052527 · Alpha Omega Engineering , Ltd. · Apr 2006
NEURODRIVE SYSTEM
K051830 · Alpha Omega , Ltd. · Sep 2005
NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
K042384 · Cyberkinetics, Inc. (Cki) · Mar 2005