GZL · Class II · 21 CFR 882.1330

FDA Product Code GZL: Electrode, Depth

Leading manufacturers include Alpha Omega Engineering , Ltd., Ad-Tech Medical Instrument Corporation and Ice Neurosystems, Inc..

58
Total
58
Cleared
175d
Avg days
1980
Since
Declining activity - 3 submissions in the last 2 years vs 6 in the prior period
Review times improving: avg 142d recently vs 177d historically

FDA 510(k) Cleared Electrode, Depth Devices (Product Code GZL)

58 devices
1–24 of 58
Cleared Apr 17, 2026
Wovyn Depth Electrode
K253970
Sensomedical Labs, Ltd.
Neurology · 127d
Cleared Nov 05, 2025
Depth Electrode (RSDE-08)
K250363
Beijing Sinovation Medical Technology Co., Ltd.
Neurology · 268d
Cleared Mar 30, 2025
Neuro Omega System
K250601
Alpha Omega Engineering , Ltd.
Neurology · 30d
Cleared May 18, 2023
Spencer Probe Depth Electrodes
K223269
Ad-Tech Medical Instrument Corporation
Neurology · 206d
Cleared May 18, 2023
Anchor Bolts as Accessories to Depth Electrodes
K223276
Ad-Tech Medical Instrument Corporation
Neurology · 206d
Cleared Apr 18, 2023
SENSOSEEG Depth Electrodes
K213170
Sensomedical Labs, Ltd.
Neurology · 567d
Cleared Dec 06, 2022
iCE-SG2 Subcutaneous Electrode Kit
K222706
Ice Neurosystems, Inc.
Neurology · 90d
Cleared Oct 20, 2022
Evo® sEEG System
K222404
Neuroone Medical Technologies Corp.
Neurology · 72d
Cleared Sep 16, 2022
Neuro Omega System, NeuroSmart System
K220553
Alpha Omega Engineering , Ltd.
Neurology · 200d
Cleared Nov 18, 2021
DIXI Medical Microdeep Micro-Macro Depth Electrodes
K202087
Dixi Medical
Neurology · 478d
Cleared Sep 01, 2021
Evo sEEG System
K211367
Neuroone Medical Technologies Corp.
Neurology · 120d
Cleared Mar 08, 2021
iCE-SG Subcutaneous Electrode Arrays
K201678
Ice Neurosystems, Inc.
Neurology · 262d
Cleared Jan 02, 2020
Sterile LeadConfirm
K191739
Alpha Omega Engineering , Ltd.
Neurology · 188d
Cleared Dec 20, 2018
microTargeting Guideline 4000 5.0 System
K183123
FHC, Inc.
Neurology · 37d
Cleared Aug 09, 2018
Anchor Bolt (as an accessory to Depth Electrodes)
K181544
Ad-Tech Medical Instrument Corporation
Neurology · 58d
Cleared Feb 27, 2018
NeuroNav System, NeuroSmart System
K172042
Alpha Omega Engineering , Ltd.
Neurology · 236d

About Product Code GZL - Regulatory Context

510(k) Submission Activity

58 total 510(k) submissions under product code GZL since 1980, with 58 receiving FDA clearance (average review time: 175 days).

Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 6 in the prior period.

FDA 510(k) Review Time - GZL Product Code

Recent submissions under GZL have taken an average of 142 days to reach a decision - down from 177 days historically, suggesting improved FDA processing for this classification.

GZL devices are reviewed by the Neurology panel. Browse all Neurology devices →