Cleared Traditional

K033173 - MICRO TARGETING ELECTRODE (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033173 · FHC, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Mar 2004
Decision
175d
Days
Class 2
Risk

K033173 is an FDA 510(k) clearance for the MICRO TARGETING ELECTRODE. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by FHC, Inc. (Bowdoinham, US). The FDA issued a Cleared decision on March 24, 2004 after a review of 175 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 FHC, Inc. devices

Submission Details

510(k) Number K033173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2003
Decision Date March 24, 2004
Days to Decision 175 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 148d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 57
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K033173.
Wovyn Depth Electrode
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Spencer Probe Depth Electrodes
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Anchor Bolts as Accessories to Depth Electrodes
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SENSOSEEG Depth Electrodes
K213170 · Sensomedical Labs, Ltd. · Apr 2023