FDA Product Code
FDA Product Code GZL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1330
510(k) Clearances — 58 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253970 | Wovyn Depth Electrode | Sensomedical Labs, Ltd. | 2026-04-17 | Traditional | PDF ↗ |
| 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 (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); Dept | Beijing Sinovation Medical Technology Co., Ltd. | 2025-11-05 | Traditional | PDF ↗ |
| K250601 | Neuro Omega System; NeuroSmart System | Alpha Omega Engineering , Ltd. | 2025-03-30 | Special | PDF ↗ |
| K223276 | Anchor Bolts as Accessories to Depth Electrodes | Ad-Tech Medical Instrument Corporation | 2023-05-18 | Traditional | PDF ↗ |
| K223269 | Spencer Probe Depth Electrodes | Ad-Tech Medical Instrument Corporation | 2023-05-18 | Traditional | PDF ↗ |
| K213170 | SENSOSEEG Depth Electrodes | Sensomedical Labs, Ltd. | 2023-04-18 | Traditional | PDF ↗ |
| K222706 | iCE-SG2 Subcutaneous Electrode Kit | Ice Neurosystems, Inc. | 2022-12-06 | Traditional | PDF ↗ |
| K222404 | Evo® sEEG System | Neuroone Medical Technologies Corp. | 2022-10-20 | Traditional | PDF ↗ |
| K220553 | Neuro Omega System, NeuroSmart System | Alpha Omega Engineering , Ltd. | 2022-09-16 | Special | PDF ↗ |
| K202087 | DIXI Medical Microdeep Micro-Macro Depth Electrodes | Dixi Medical | 2021-11-18 | Traditional | PDF ↗ |
| K211367 | Evo sEEG System | Neuroone Medical Technologies Corp. | 2021-09-01 | Traditional | PDF ↗ |
| K201678 | iCE-SG Subcutaneous Electrode Arrays | Ice Neurosystems, Inc. | 2021-03-08 | Traditional | PDF ↗ |
| K191739 | Sterile LeadConfirm | Alpha Omega Engineering , Ltd. | 2020-01-02 | Traditional | PDF ↗ |
| K183123 | microTargeting Guideline 4000 5.0 System | FHC, Inc. | 2018-12-20 | Special | PDF ↗ |
| K181544 | Anchor Bolt (as an accessory to Depth Electrodes) | Ad-Tech Medical Instrument Corporation | 2018-08-09 | Traditional | PDF ↗ |
| K172042 | NeuroNav System, NeuroSmart System | Alpha Omega Engineering , Ltd. | 2018-02-27 | Traditional | PDF ↗ |
| K171581 | Neuro Omega System | Alpha Omega Engineering , Ltd. | 2017-12-22 | Traditional | PDF ↗ |
| K170959 | DIXI Medical Microdeep Depth Electrode | Dixi Medical | 2017-11-24 | Traditional | PDF ↗ |
| K162459 | AccuPoint Electrode | Microprobes For Life Science, Inc. Dba Neuron | 2017-06-15 | Traditional | PDF ↗ |
| K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes | Ad-Tech Medical Instrument Corporation | 2017-04-12 | Traditional | PDF ↗ |
| K151790 | PMT Platinum Depthalon Depth Electrode | Pmt Corporation | 2016-07-14 | Traditional | PDF ↗ |
| K152547 | DNAP Electrode | Ad-Tech Medical Instrument Corporation | 2016-03-04 | Traditional | PDF ↗ |
| K140680 | LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM | Alpine Biomed Aps | 2014-12-12 | Traditional | PDF ↗ |
| K123796 | NEURO OMEGA SYSTEM | Alpha Omega Engineering , Ltd. | 2013-04-05 | Traditional | PDF ↗ |
| K120098 | STERILE DISPOSABLES FOR MER | Alpha Omega Engineering , Ltd. | 2012-06-12 | Traditional | PDF ↗ |
| K110010 | NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM | Blackrock Microsystems, Inc. | 2011-02-09 | Special | PDF ↗ |
| K082404 | NAVIGATION PROBES | We Sense, Ltd. | 2009-02-25 | Traditional | PDF ↗ |
| K071697 | NEURONAV SYSTEM AND NEURONAV DRIVE | Alpha Omega , Ltd. | 2007-12-03 | Traditional | PDF ↗ |
| K070272 | NEUROPORT ELECTRODE | Cyberkinetics Neurotechnology Systems, Inc. | 2007-08-03 | Traditional | PDF ↗ |
| K071364 | MICROTARGETING GUIDELINE 4000 | FHC, Inc. | 2007-07-25 | Traditional | PDF ↗ |
| K053358 | DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES | Ad-Tech Medical Instrument Corp | 2006-05-25 | Abbreviated | PDF ↗ |
| K052527 | NEUROPROBES | Alpha Omega Engineering , Ltd. | 2006-04-12 | Traditional | PDF ↗ |
| K051830 | NEURODRIVE SYSTEM | Alpha Omega , Ltd. | 2005-09-16 | Traditional | PDF ↗ |
| K042384 | NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM | Cyberkinetics, Inc. (Cki) | 2005-03-29 | Traditional | PDF ↗ |
| K042208 | ISIS MER SYSTEM/ELEKTA MER SYSTEM | Inomed Medizintechnik GmbH | 2005-03-18 | Traditional | PDF ↗ |
| K041409 | MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799 | Inomed GmbH | 2004-08-20 | Traditional | PDF ↗ |
| K041604 | MACRO-MICRO DEPTH ELECTRODE | Ad-Tech Medical Instrument Corp | 2004-08-16 | Abbreviated | PDF ↗ |
| K033730 | PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES | Pmt Corp. | 2004-08-03 | Traditional | PDF ↗ |
| K033173 | MICRO TARGETING ELECTRODE | FHC, Inc. | 2004-03-24 | Traditional | PDF ↗ |
| K012850 | RECORDING AND STIMULATING ELECTRODE | Radionics, A Division of Tyco Healthcare Group LP | 2001-11-19 | Traditional | PDF ↗ |
| K991522 | MICROTARGETING ELECTRODE | FHC, Inc. | 2000-08-04 | Traditional | PDF ↗ |
| K993622 | NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY | Alpha Omega , Ltd. | 2000-01-24 | Traditional | PDF ↗ |
| K990788 | AD-TECH'S FORAMEN OVALE ELECTRODE | Ad-Tech Medical Instrument Corp | 1999-11-02 | Traditional | PDF ↗ |
| K991077 | MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000) | Microrecording Systems Consultants, LLC | 1999-06-09 | Traditional | PDF ↗ |
| K981820 | NEUROMAP | Radionics, Inc. | 1998-11-20 | Traditional | PDF ↗ |
| K981015 | PALI-TRODE | Preferred Instruments | 1998-06-16 | Traditional | PDF ↗ |
| K973454 | AD-TECH'S SPINAL ELECTRODE | Ad-Tech Medical Instrument Corp | 1998-06-10 | Traditional | PDF ↗ |
| K970943 | GUIDELINE SYSTEM | Axon Instruments, Inc. | 1997-08-18 | Traditional | PDF ↗ |
| K964644 | AD-TECH'S DEPTH ELECTRODE | Ad-Tech Medical Instrument Corp | 1997-05-09 | Traditional | PDF ↗ |
| K970418 | PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX) | Pmt Corp. | 1997-04-29 | Traditional | PDF ↗ |
| K946018 | TENS-IT, FITTRONIC II, (MORE LATER) | Ems, Inc. | 1995-11-09 | Traditional | PDF ↗ |
| K944061 | CUEVA CRANIAL NERVE ELECTRODE | Ad-Tech Medical Instrument Corp | 1995-01-20 | Traditional | PDF ↗ |
| K902976 | MEDI MODEL SBL502-B (LISS BODY STIMULATOR) ZERO DC | Medical Consultants Intl. , Ltd. | 1990-09-07 | Traditional | PDF ↗ |
| K891920 | AD-TECH'S DEPTH ELECTRODE | Ad-Tech Medical Instrument Corp | 1989-07-27 | Traditional | PDF ↗ |
| K861031 | WYLER SPHENOIDAL ELECTRODE | Ad-Tech Medical Instrument Corp | 1986-08-25 | Traditional | PDF ↗ |
| K802152 | PMT DEPTHALON DEPTH #2102 | Progress Mankind Technology | 1980-11-19 | Traditional | PDF ↗ |
| K802151 | PMT DEPTHALON DEPTH CORTICOGRAPHY ELEC | Progress Mankind Technology | 1980-11-19 | Traditional | PDF ↗ |
| K802249 | MICROLET FAMILY OF NEEDLE/DEPTH ELECT- | Progress Mankind Technology | 1980-11-19 | Traditional | PDF ↗ |
Product code GZL · Class II · Neurology. Data: openFDA.