Cleared Traditional

K253970 - Wovyn Depth Electrode

K253970 is an FDA 510(k) clearance for Wovyn Depth Electrode, manufactured by Sensomedical Labs, Ltd.. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K253970 · Sensomedical Labs, Ltd. · Neurology device
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Optimized for regulatory review, auditing and printing
Apr 2026
Decision
127d
Days
Class 2
Risk

K253970 is an FDA 510(k) clearance for the Wovyn Depth Electrode. 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 17, 2026 after a review of 127 days - within the typical 510(k) review window.

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 Sensomedical Labs, Ltd. devices

FDA 510(k) Submission Details - K253970

510(k) Number K253970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2025
Decision Date April 17, 2026
Days to Decision 127 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
21d faster than avg
Panel avg: 148d · This submission: 127d
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 52
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K253970.
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
SENSOSEEG Depth Electrodes
K213170 · Sensomedical Labs, Ltd. · Apr 2023
iCE-SG2 Subcutaneous Electrode Kit
K222706 · Ice Neurosystems, Inc. · Dec 2022