Electrode, Depth
FDA product code GZL · Class II (moderate risk) · 21 CFR 882.1330 · Neurology
58510(k) clearances
0PMA approvals
24recalls
Manufacturers
- Ad-Tech Medical Instrument Corporation 13
- Alpha Omega Engineering , Ltd. 8
- FHC, Inc. 4
- Pmt Corp. 3
- Progress Mankind Technology 3
- Alpha Omega , Ltd. 3
- Dixi Medical 2
- Ice Neurosystems, Inc. 2
- Neuroone Medical Technologies Corp. 2
- Sensomedical Labs, Ltd. 2
- Microrecording Systems Consultants, LLC 1
- Radionics, Inc. 1
- Radionics, A Division of Tyco Healthcare Group LP 1
- Inomed GmbH 1
- Inomed Medizintechnik GmbH 1
- Beijing Sinovation Medical Technology Co., Ltd. 1
- Medical Consultants Intl. , Ltd. 1
- We Sense, Ltd. 1
- Blackrock Microsystems 1
- Axon Instruments, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253970 | Wovyn Depth ElectrodeGZL · Traditional | Sensomedical Labs, Ltd. | 04/17/2026SE |
| K250363 | Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth…GZL · Traditional | Beijing Sinovation Medical Technology Co., Ltd. | 11/05/2025SE |
| K250601 | Neuro Omega System; NeuroSmart SystemGZL · Special | Alpha Omega Engineering , Ltd. | 03/30/2025SE |
| K223276 | Anchor Bolts as Accessories to Depth ElectrodesGZL · Traditional | Ad-Tech Medical Instrument Corporation | 05/18/2023SE |
| K223269 | Spencer Probe Depth ElectrodesGZL · Traditional | Ad-Tech Medical Instrument Corporation | 05/18/2023SE |
| K213170 | SENSOSEEG Depth ElectrodesGZL · Traditional | Sensomedical Labs, Ltd. | 04/18/2023SE |
| K222706 | iCE-SG2 Subcutaneous Electrode KitGZL · Traditional | Ice Neurosystems, Inc. | 12/06/2022SE |
| K222404 | Evo® sEEG SystemGZL · Traditional | Neuroone Medical Technologies Corp. | 10/20/2022SE |
| K220553 | Neuro Omega System, NeuroSmart SystemGZL · Special | Alpha Omega Engineering , Ltd. | 09/16/2022SE |
| K202087 | DIXI Medical Microdeep Micro-Macro Depth ElectrodesGZL · Traditional | Dixi Medical | 11/18/2021SE |
| K211367 | Evo sEEG SystemGZL · Traditional | Neuroone Medical Technologies Corp. | 09/01/2021SE |
| K201678 | iCE-SG Subcutaneous Electrode ArraysGZL · Traditional | Ice Neurosystems, Inc. | 03/08/2021SE |
| K191739 | Sterile LeadConfirmGZL · Traditional | Alpha Omega Engineering , Ltd. | 01/02/2020SE |
| K183123 | microTargeting Guideline 4000 5.0 SystemGZL · Special | FHC, Inc. | 12/20/2018SE |
| K181544 | Anchor Bolt (as an accessory to Depth Electrodes)GZL · Traditional | Ad-Tech Medical Instrument Corporation | 08/09/2018SE |
| K172042 | NeuroNav System, NeuroSmart SystemGZL · Traditional | Alpha Omega Engineering , Ltd. | 02/27/2018SE |
| K171581 | Neuro Omega SystemGZL · Traditional | Alpha Omega Engineering , Ltd. | 12/22/2017SE |
| K170959 | DIXI Medical Microdeep Depth ElectrodeGZL · Traditional | Dixi Medical | 11/24/2017SE |
| K162459 | AccuPoint ElectrodeGZL · Traditional | Microprobes For Life Science, Inc. Dba Neuron | 06/15/2017SE |
| K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer…GZL · Traditional | Ad-Tech Medical Instrument Corporation | 04/12/2017SE |
| K151790 | PMT Platinum Depthalon Depth ElectrodeGZL · Traditional | Pmt Corporation | 07/14/2016SE |
| K152547 | DNAP ElectrodeGZL · Traditional | Ad-Tech Medical Instrument Corporation | 03/04/2016SE |
| K140680 | Leadpoint Focus Workststion, Leadpoint Focus Notebook SystemGZL · Traditional | Alpine Biomed Aps | 12/12/2014SE |
| K123796 | Neuro Omega SystemGZL · Traditional | Alpha Omega Engineering , Ltd. | 04/05/2013SE |
| K120098 | Sterile Disposables for MerGZL · Traditional | Alpha Omega Engineering , Ltd. | 06/12/2012SE |
| K110010 | Neuroport Cortical Microelectrode Array SystemGZL · Special | Blackrock Microsystems, Inc. | 02/09/2011SE |
| K082404 | Navigation ProbesGZL · Traditional | We Sense, Ltd. | 02/25/2009SE |
| K071697 | Neuronav System and Neuronav DriveGZL · Traditional | Alpha Omega , Ltd. | 12/03/2007SE |
| K070272 | Neuroport ElectrodeGZL · Traditional | Cyberkinetics Neurotechnology Systems, Inc. | 08/03/2007SE |
| K071364 | Microtargeting Guideline 4000GZL · Traditional | FHC, Inc. | 07/25/2007SE |
| K053358 | Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth ElectrodesGZL · Abbreviated | Ad-Tech Medical Instrument Corp | 05/25/2006SE |
| K052527 | NeuroprobesGZL · Traditional | Alpha Omega Engineering , Ltd. | 04/12/2006SE |
| K051830 | Neurodrive SystemGZL · Traditional | Alpha Omega , Ltd. | 09/16/2005SE |
| K042384 | Neuroport Recording Microelectrode Array SystemGZL · Traditional | Cyberkinetics, Inc. (Cki) | 03/29/2005SE |
| K042208 | Isis Mer System/Elekta Mer SystemGZL · Traditional | Inomed Medizintechnik GmbH | 03/18/2005SE |
| K041409 | Micro-Recording and Stimulation Electrodes-Micro Macroelectrode Model No. 230700-230799GZL · Traditional | Inomed GmbH | 08/20/2004SE |
| K041604 | Macro-Micro Depth ElectrodeGZL · Abbreviated | Ad-Tech Medical Instrument Corp | 08/16/2004SE |
| K033730 | PMT Sphenoidal Electrode and Accessory, Model 2101-31 and 2102-31 SeriesGZL · Traditional | Pmt Corp. | 08/03/2004SE |
| K033173 | Micro Targeting ElectrodeGZL · Traditional | FHC, Inc. | 03/24/2004SE |
| K012850 | Recording and Stimulating ElectrodeGZL · Traditional | Radionics, A Division of Tyco Healthcare Group LP | 11/19/2001SE |
| K991522 | Microtargeting ElectrodeGZL · Traditional | FHC, Inc. | 08/04/2000SE |
| K993622 | Neurotrek Physiological Navigation System for NeurosurgeryGZL · Traditional | Alpha Omega , Ltd. | 01/24/2000SE |
| K990788 | Ad-Tech's Foramen Ovale ElectrodeGZL · Traditional | Ad-Tech Medical Instrument Corp | 11/02/1999SE |
| K991077 | Microelectroencephalography Professional System 5000 (EEG Pro System 5000)GZL · Traditional | Microrecording Systems Consultants, LLC | 06/09/1999SE |
| K981820 | NeuromapGZL · Traditional | Radionics, Inc. | 11/20/1998SE |
| K981015 | Pali-TrodeGZL · Traditional | Preferred Instruments | 06/16/1998SE |
| K973454 | Ad-Tech's Spinal ElectrodeGZL · Traditional | Ad-Tech Medical Instrument Corp | 06/10/1998SE |
| K970943 | Guideline SystemGZL · Traditional | Axon Instruments, Inc. | 08/18/1997SE |
| K964644 | Ad-Tech's Depth ElectrodeGZL · Traditional | Ad-Tech Medical Instrument Corp | 05/09/1997SE |
| K970418 | PMT Accessory Depthalon Electrode Anchor Bolt (2103-23-XX)GZL · Traditional | Pmt Corp. | 04/29/1997SE |
| K946018 | Tens-It, Fittronic II, (More Later)GZL · Traditional | Ems, Inc. | 11/09/1995SE |
| K944061 | Cueva Cranial Nerve ElectrodeGZL · Traditional | Ad-Tech Medical Instrument Corp | 01/20/1995SE |
| K902976 | Medi Model SBL502-B (Liss Body Stimulator) Zero DCGZL · Traditional | Medical Consultants Intl. , Ltd. | 09/07/1990SE |
| K891920 | Ad-Tech's Depth ElectrodeGZL · Traditional | Ad-Tech Medical Instrument Corp | 07/27/1989SE |
| K861031 | Wyler Sphenoidal ElectrodeGZL · Traditional | Ad-Tech Medical Instrument Corp | 08/25/1986SE |
| K802249 | Microlet Family of Needle/Depth Elect-GZL · Traditional | Progress Mankind Technology | 11/19/1980SE |
| K802152 | PMT Depthalon Depth #2102GZL · Traditional | Progress Mankind Technology | 11/19/1980SE |
| K802151 | PMT Depthalon Depth Corticography ElecGZL · Traditional | Progress Mankind Technology | 11/19/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0221-2025 Class II | AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style)…Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style… | Ad-Tech Medical Instrument Corporation | 09/19/2024Completed |
| Z-0220-2025 Class II | AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style)…Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style… | Ad-Tech Medical Instrument Corporation | 09/19/2024Completed |
| Z-0219-2025 Class II | AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style)…Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style… | Ad-Tech Medical Instrument Corporation | 09/19/2024Completed |
| Z-0542-2022 Class II | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a…Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the… | Dixi Medical USA | 12/09/2021Terminated |
| Z-0541-2022 Class II | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a…Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the… | Dixi Medical USA | 12/09/2021Terminated |
| Z-0540-2022 Class II | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a…Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the… | Dixi Medical USA | 12/09/2021Terminated |
| Z-0539-2022 Class II | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a…Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the… | Dixi Medical USA | 12/09/2021Terminated |
| Z-0538-2022 Class II | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a…Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the… | Dixi Medical USA | 12/09/2021Terminated |
| Z-0537-2022 Class II | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a…Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the… | Dixi Medical USA | 12/09/2021Terminated |
| Z-0536-2022 Class II | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a…Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the… | Dixi Medical USA | 12/09/2021Terminated |
| Z-0535-2022 Class II | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a…Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the… | Dixi Medical USA | 12/09/2021Terminated |
| Z-0534-2022 Class II | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a…Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the… | Dixi Medical USA | 12/09/2021Terminated |
| Z-2540-2020 Class II | FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and…An electrical sub-circuit was not properly connected. Its purpose is to eliminate the possibility of… | FHC, Inc. | 06/17/2020Terminated |
| Z-2408-2019 Class II | Skull Anchor BoltsSupplemental information provided with devices may indicate that the subdural electrodes, depth electrodes… | Ad-Tech Medical Instrument Corporation | 06/18/2019Terminated |
| Z-2407-2019 Class II | Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer…Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and… | Ad-Tech Medical Instrument Corporation | 06/18/2019Terminated |
| Z-2204-2019 Class II | LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body…On June 12, 2019 Ad-Tech was made aware that on three different occasions between March 1, 2019 and May 31… | Ad-Tech Medical Instrument Corporation | 06/18/2019Terminated |
| Z-2396-2019 Class II | AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth…An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon encountered… | Ad-Tech Medical Instrument Corporation | 04/16/2019Terminated |
| Z-1216-2019 Class I | Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical…If cables are improperly connected, current may reach high charge density, causing tissue harm. | Alpha Omega Engineering | 09/04/2018Terminated |
| Z-0106-2015 Class II | Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch…The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing… | Ad-Tech Medical Instrument Corporation | 10/08/2014Terminated |
| Z-1143-2010 | FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software, Catalog # MT-GL4K. Intended…The raster tab for the GL4K version 1.4 software may assign incorrect depths for waveform recordings and if… | FHC, Inc. | 12/28/2009Terminated |
| Z-1553-2009 | Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog…Sterility of product cannot be assured | Cyberkinetics Neurotechnology Systems, Inc. | 02/04/2009Terminated |
| Z-0499-2009 | FC400SP microTargeting StimPilot Single Procedure Kit Distributed by Medtronic Inc.…Mislabeled: May contain an electrode longer than labeled size | FHC, Inc. | 10/20/2008Terminated |
| Z-0498-2009 | FC4000 MicroTargeting Electrode Kit 5x For use with Nexframe and Nexdrive Distributed by…Mislabeled: May contain an electrode longer than labeled size | FHC, Inc. | 10/20/2008Terminated |
| Z-0497-2009 | FHC MicroTargeting Electrode, MTDWBP(AR)(MP I ) Intended for use in intra-operative…Mislabeled: May contain an electrode longer than labeled size | FHC, Inc. | 10/20/2008Terminated |