Product code GZL
- Device name
- Electrode, Depth
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.1330
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253970 | Wovyn Depth Electrode | Sensomedical Labs, Ltd. | 2026-04-17 |
| K250363 | Depth 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 (R... | Beijing Sinovation Medical Technology Co., Ltd. | 2025-11-05 |
| K250601 | Neuro Omega System; NeuroSmart System | Alpha Omega Engineering , Ltd. | 2025-03-30 |
| K223276 | Anchor Bolts as Accessories to Depth Electrodes | Ad-Tech Medical Instrument Corporation | 2023-05-18 |
| K223269 | Spencer Probe Depth Electrodes | Ad-Tech Medical Instrument Corporation | 2023-05-18 |
| K213170 | SENSOSEEG Depth Electrodes | Sensomedical Labs, Ltd. | 2023-04-18 |
| K222706 | iCE-SG2 Subcutaneous Electrode Kit | Ice Neurosystems, Inc. | 2022-12-06 |
| K222404 | Evo® sEEG System | Neuroone Medical Technologies Corp. | 2022-10-20 |
| K220553 | Neuro Omega System, NeuroSmart System | Alpha Omega Engineering , Ltd. | 2022-09-16 |
| K202087 | DIXI Medical Microdeep Micro-Macro Depth Electrodes | Dixi Medical | 2021-11-18 |
| K211367 | Evo sEEG System | Neuroone Medical Technologies Corp. | 2021-09-01 |
| K201678 | iCE-SG Subcutaneous Electrode Arrays | Ice Neurosystems, Inc. | 2021-03-08 |
| K191739 | Sterile LeadConfirm | Alpha Omega Engineering , Ltd. | 2020-01-02 |
| K183123 | microTargeting Guideline 4000 5.0 System | FHC, Inc. | 2018-12-20 |
| K181544 | Anchor Bolt (as an accessory to Depth Electrodes) | Ad-Tech Medical Instrument Corporation | 2018-08-09 |
| K172042 | NeuroNav System, NeuroSmart System | Alpha Omega Engineering , Ltd. | 2018-02-27 |
| K171581 | Neuro Omega System | Alpha Omega Engineering , Ltd. | 2017-12-22 |
| K170959 | DIXI Medical Microdeep Depth Electrode | Dixi Medical | 2017-11-24 |
| K162459 | AccuPoint Electrode | Microprobes For Life Science, Inc. Dba Neuron | 2017-06-15 |
| K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes | Ad-Tech Medical Instrument Corporation | 2017-04-12 |
| K151790 | PMT Platinum Depthalon Depth Electrode | Pmt Corporation | 2016-07-14 |
| K152547 | DNAP Electrode | Ad-Tech Medical Instrument Corporation | 2016-03-04 |
| K140680 | LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM | Alpine Biomed Aps | 2014-12-12 |
| K123796 | NEURO OMEGA SYSTEM | Alpha Omega Engineering , Ltd. | 2013-04-05 |
| K120098 | STERILE DISPOSABLES FOR MER | Alpha Omega Engineering , Ltd. | 2012-06-12 |
| K110010 | NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM | Blackrock Microsystems, Inc. | 2011-02-09 |
| K082404 | NAVIGATION PROBES | We Sense, Ltd. | 2009-02-25 |
| K071697 | NEURONAV SYSTEM AND NEURONAV DRIVE | Alpha Omega , Ltd. | 2007-12-03 |
| K070272 | NEUROPORT ELECTRODE | Cyberkinetics Neurotechnology Systems, Inc. | 2007-08-03 |
| K071364 | MICROTARGETING GUIDELINE 4000 | FHC, Inc. | 2007-07-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10873263009625 | microTargeting™ Electrode | FHC, INC. | 2026-03-12 |
| 10873263009496 | microTargeting™ Electrode | FHC, INC. | 2025-12-02 |
| 10873263009410 | microTargeting™ Electrode | FHC, INC. | 2025-05-21 |
| 10873263008802 | microTargeting™ Electrode | FHC, INC. | 2025-04-30 |
| 10873263008918 | microTargeting™ Electrode and Insertion Tube Kit | FHC, INC. | 2025-04-30 |
| 10873263008888 | microTargeting™ Electrode | FHC, INC. | 2025-04-30 |
| 10873263008871 | microTargeting™ Electrode and Insertion Tube Kit | FHC, INC. | 2025-04-30 |
| 10873263008857 | microTargeting™ Electrode | FHC, INC. | 2025-04-30 |
| 10873263008840 | microTargeting™ Electrode | FHC, INC. | 2025-04-30 |
| 10873263008833 | microTargeting™ Electrode | FHC, INC. | 2025-04-30 |
| 10873263008826 | microTargeting™ Electrode | FHC, INC. | 2025-04-30 |
| 10873263008819 | microTargeting™ Electrode | FHC, INC. | 2025-04-30 |
| 10873263008796 | microTargeting™ Electrode | FHC, INC. | 2025-04-30 |
| 10873263008789 | microTargeting™ Electrode | FHC, INC. | 2025-04-30 |
| 10873263009250 | microTargeting™ Electrode | FHC, INC. | 2024-09-02 |
| 10873263009205 | microTargeting™ Electrode | FHC, INC. | 2024-04-12 |
| 10873263008680 | microTargeting™ Electrode | FHC, INC. | 2023-03-10 |
| 10873263008635 | microTargeting™ Electrode | FHC, INC. | 2022-09-26 |
| 27290016450976 | Leksell Non-XY frame Mechanical Set Kit | ALPHA OMEGA ENGINEERING CO. LTD. | 2020-06-01 |
| 27290014954094 | Libenger RM frame Mechanical Set KIT | ALPHA OMEGA ENGINEERING CO. LTD. | 2020-06-01 |
| 27290014954100 | Starfix frame Mechanical Set Kit | ALPHA OMEGA ENGINEERING CO. LTD. | 2020-06-01 |
| 27290016450815 | NexFrame Mechanical Set Kit | ALPHA OMEGA ENGINEERING CO. LTD. | 2020-06-01 |
| 27290016450952 | CRW Non-XY frame Mechanical Set KIT | ALPHA OMEGA ENGINEERING CO. LTD. | 2020-06-01 |
| 10873263007584 | microTargeting™ Electrode and Insertion Tube Kit | FHC, INC. | 2019-12-27 |
| 10873263007539 | microTargeting™ Electrode and Insertion Tube | FHC, INC. | 2019-12-27 |
| 10873263001346 | microTargeting™ Electrode and Insertion Tube Kit | FHC, INC. | 2016-08-22 |
| 10873263001162 | microTargeting™ Electrode and Insertion Tube Kit | FHC, INC. | 2016-08-22 |
| 10873263001155 | microTargeting™ Electrode and Insertion Tube | FHC, INC. | 2016-08-22 |
| 10381780037088 | Integra® | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780034766 | Integra® | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |