Cleared Traditional

K213170 - SENSOSEEG Depth Electrodes (FDA 510(k) Clearance)

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

K213170 · Sensomedical Labs, Ltd. · Neurology device
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Apr 2023
Decision
567d
Days
Class 2
Risk

K213170 is an FDA 510(k) clearance for the SENSOSEEG Depth Electrodes. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Sensomedical Labs, Ltd. (Nazareth, IL). The FDA issued a Cleared decision on April 18, 2023 after a review of 567 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Sensomedical Labs, Ltd. devices

Submission Details

510(k) Number K213170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2021
Decision Date April 18, 2023
Days to Decision 567 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
419d slower than avg
Panel avg: 148d · This submission: 567d
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 K213170.
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
Anchor Bolts as Accessories to Depth Electrodes
K223276 · Ad-Tech Medical Instrument Corporation · May 2023
iCE-SG2 Subcutaneous Electrode Kit
K222706 · Ice Neurosystems, Inc. · Dec 2022