Cleared Abbreviated

K041604 - MACRO-MICRO DEPTH ELECTRODE

K041604 is an FDA 510(k) clearance for MACRO-MICRO 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 63-day FDA review.

K041604 · 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
Aug 2004
Decision
63d
Days
Class 2
Risk

K041604 is an FDA 510(k) clearance for the MACRO-MICRO DEPTH ELECTRODE. 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 August 16, 2004 after a review of 63 days - a notably fast clearance 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 - K041604

510(k) Number K041604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2004
Decision Date August 16, 2004
Days to Decision 63 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
86d faster than avg
Panel avg: 149d · This submission: 63d
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 K041604.
NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
K042384 · Cyberkinetics, Inc. (Cki) · Mar 2005
ISIS MER SYSTEM/ELEKTA MER SYSTEM
K042208 · Inomed Medizintechnik GmbH · Mar 2005
MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799
K041409 · Inomed GmbH · Aug 2004
PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES
K033730 · Pmt Corp. · Aug 2004
MICRO TARGETING ELECTRODE
K033173 · FHC, Inc. · Mar 2004
RECORDING AND STIMULATING ELECTRODE
K012850 · Radionics, A Division of Tyco Healthcare Group LP · Nov 2001