Cleared Traditional

K964644 - AD-TECH'S DEPTH ELECTRODE

K964644 is an FDA 510(k) clearance for AD-TECH'S DEPTH ELECTRODE, manufactured by Ad-Tech Medical Instrument Corp. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K964644 · Ad-Tech Medical Instrument Corp · Neurology device
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May 1997
Decision
190d
Days
Class 2
Risk

K964644 is an FDA 510(k) clearance for the AD-TECH'S DEPTH ELECTRODE. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Ad-Tech Medical Instrument Corp (Racine, US). The FDA issued a Cleared decision on May 9, 1997 after a review of 190 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 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 Ad-Tech Medical Instrument Corp devices

FDA 510(k) Submission Details - K964644

510(k) Number K964644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1996
Decision Date May 09, 1997
Days to Decision 190 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 148d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 24
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K964644.
AD-TECH'S FORAMEN OVALE ELECTRODE
K990788 · Ad-Tech Medical Instrument Corp · Nov 1999
NEUROMAP
K981820 · Radionics, Inc. · Nov 1998
AD-TECH'S SPINAL ELECTRODE
K973454 · Ad-Tech Medical Instrument Corp · Jun 1998
PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX)
K970418 · Pmt Corp. · Apr 1997
CUEVA CRANIAL NERVE ELECTRODE
K944061 · Ad-Tech Medical Instrument Corp · Jan 1995