Cleared Traditional

K223276 - Anchor Bolts as Accessories to Depth Electrodes (FDA 510(k) Clearance)

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

K223276 · Ad-Tech Medical Instrument Corporation · Neurology device
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May 2023
Decision
206d
Days
Class 2
Risk

K223276 is an FDA 510(k) clearance for the Anchor Bolts as Accessories to Depth Electrodes. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Ad-Tech Medical Instrument Corporation (Oak Creek, US). The FDA issued a Cleared decision on May 18, 2023 after a review of 206 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 Corporation devices

Submission Details

510(k) Number K223276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2022
Decision Date May 18, 2023
Days to Decision 206 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
58d slower than avg
Panel avg: 148d · This submission: 206d
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 Consultant

Namsa Medical Research Organization
Linford Leitch

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GZL Electrode, Depth

All 57
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K223276.
Wovyn Depth Electrode
K253970 · Sensomedical Labs, Ltd. · Apr 2026
Depth Electrode (RSDE-08)
K250363 · Beijing Sinovation Medical Technology Co., Ltd. · Nov 2025
Neuro Omega System
K250601 · Alpha Omega Engineering , Ltd. · Mar 2025
Spencer Probe Depth Electrodes
K223269 · Ad-Tech Medical Instrument Corporation · May 2023
SENSOSEEG Depth Electrodes
K213170 · Sensomedical Labs, Ltd. · Apr 2023
iCE-SG2 Subcutaneous Electrode Kit
K222706 · Ice Neurosystems, Inc. · Dec 2022