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510(k) K253970

Device
Wovyn Depth Electrode
Applicant
Sensomedical Labs, Ltd.
510(k) number
K253970
Product code
GZL
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-17
Date received
2025-12-11
Regulation
882.1330
Classification name
Electrode, Depth
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Maroun Farah
Address
Nazareth Industrial Park, Mount Precipice Nazareth IL 1612102 1612102

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GZL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250363Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); DeptBeijing Sinovation Medical Technology Co., Ltd.2025-11-05
K250601Neuro Omega System; NeuroSmart SystemAlpha Omega Engineering , Ltd.2025-03-30
K223276Anchor Bolts as Accessories to Depth ElectrodesAd-Tech Medical Instrument Corporation2023-05-18
K223269Spencer Probe Depth ElectrodesAd-Tech Medical Instrument Corporation2023-05-18
K213170SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd.2023-04-18
K222706iCE-SG2 Subcutaneous Electrode KitIce Neurosystems, Inc.2022-12-06
K222404Evo® sEEG SystemNeuroone Medical Technologies Corp.2022-10-20
K220553Neuro Omega System, NeuroSmart SystemAlpha Omega Engineering , Ltd.2022-09-16
K202087DIXI Medical Microdeep Micro-Macro Depth ElectrodesDixi Medical2021-11-18
K211367Evo sEEG SystemNeuroone Medical Technologies Corp.2021-09-01
K201678iCE-SG Subcutaneous Electrode ArraysIce Neurosystems, Inc.2021-03-08
K191739Sterile LeadConfirmAlpha Omega Engineering , Ltd.2020-01-02
K183123microTargeting Guideline 4000 5.0 SystemFHC, Inc.2018-12-20
K181544Anchor Bolt (as an accessory to Depth Electrodes)Ad-Tech Medical Instrument Corporation2018-08-09
K172042NeuroNav System, NeuroSmart SystemAlpha Omega Engineering , Ltd.2018-02-27