Atlas FDA

GZL

58 FDA 510(k) clearances · Product code

174 daysmedian time to decision
286 days90th percentile
58clearances measured

FDA profile

Official device name
Electrode, Depth
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1330
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
2016: 9 · 2019: 13 · 2020: 24 · 2021: 13 · 2023: 30 · 2024: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Wovyn Depth Electrode (K253970)Sensomedical Labs, Ltd.2026-04-17
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 (K250363)Beijing Sinovation Medical Technology Co., Ltd.2025-11-05
Neuro Omega System; NeuroSmart System (K250601)Alpha Omega Engineering , Ltd.2025-03-30
Spencer Probe Depth Electrodes (K223269)Ad-Tech Medical Instrument Corporation2023-05-18
Anchor Bolts as Accessories to Depth Electrodes (K223276)Ad-Tech Medical Instrument Corporation2023-05-18
SENSOSEEG Depth Electrodes (K213170)Sensomedical Labs, Ltd.2023-04-18
iCE-SG2 Subcutaneous Electrode Kit (K222706)Ice Neurosystems, Inc.2022-12-06
Evo® sEEG System (K222404)Neuroone Medical Technologies Corp.2022-10-20
Neuro Omega System, NeuroSmart System (K220553)Alpha Omega Engineering , Ltd.2022-09-16
DIXI Medical Microdeep Micro-Macro Depth Electrodes (K202087)Dixi Medical2021-11-18
Evo sEEG System (K211367)Neuroone Medical Technologies Corp.2021-09-01
iCE-SG Subcutaneous Electrode Arrays (K201678)Ice Neurosystems, Inc.2021-03-08
Sterile LeadConfirm (K191739)Alpha Omega Engineering , Ltd.2020-01-02
microTargeting Guideline 4000 5.0 System (K183123)FHC, Inc.2018-12-20
Anchor Bolt (as an accessory to Depth Electrodes) (K181544)Ad-Tech Medical Instrument Corporation2018-08-09
NeuroNav System, NeuroSmart System (K172042)Alpha Omega Engineering , Ltd.2018-02-27
Neuro Omega System (K171581)Alpha Omega Engineering , Ltd.2017-12-22
DIXI Medical Microdeep Depth Electrode (K170959)Dixi Medical2017-11-24
AccuPoint Electrode (K162459)Microprobes For Life Science, Inc. Dba Neuron2017-06-15
Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes (K163355)Ad-Tech Medical Instrument Corporation2017-04-12
PMT Platinum Depthalon Depth Electrode (K151790)Pmt Corporation2016-07-14
DNAP Electrode (K152547)Ad-Tech Medical Instrument Corporation2016-03-04
LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM (K140680)Alpine Biomed Aps2014-12-12
NEURO OMEGA SYSTEM (K123796)Alpha Omega Engineering , Ltd.2013-04-05
STERILE DISPOSABLES FOR MER (K120098)Alpha Omega Engineering , Ltd.2012-06-12
NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM (K110010)Blackrock Microsystems, Inc.2011-02-09
NAVIGATION PROBES (K082404)We Sense, Ltd.2009-02-25
NEURONAV SYSTEM AND NEURONAV DRIVE (K071697)Alpha Omega , Ltd.2007-12-03
NEUROPORT ELECTRODE (K070272)Cyberkinetics Neurotechnology Systems, Inc.2007-08-03
MICROTARGETING GUIDELINE 4000 (K071364)FHC, Inc.2007-07-25
DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES (K053358)Ad-Tech Medical Instrument Corp2006-05-25
NEUROPROBES (K052527)Alpha Omega Engineering , Ltd.2006-04-12
NEURODRIVE SYSTEM (K051830)Alpha Omega , Ltd.2005-09-16
NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM (K042384)Cyberkinetics, Inc. (Cki)2005-03-29
ISIS MER SYSTEM/ELEKTA MER SYSTEM (K042208)Inomed Medizintechnik GmbH2005-03-18
MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799 (K041409)Inomed GmbH2004-08-20
MACRO-MICRO DEPTH ELECTRODE (K041604)Ad-Tech Medical Instrument Corp2004-08-16
PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES (K033730)Pmt Corp.2004-08-03
MICRO TARGETING ELECTRODE (K033173)FHC, Inc.2004-03-24
RECORDING AND STIMULATING ELECTRODE (K012850)Radionics, A Division of Tyco Healthcare Group LP2001-11-19
MICROTARGETING ELECTRODE (K991522)FHC, Inc.2000-08-04
NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY (K993622)Alpha Omega , Ltd.2000-01-24
AD-TECH'S FORAMEN OVALE ELECTRODE (K990788)Ad-Tech Medical Instrument Corp1999-11-02
MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000) (K991077)Microrecording Systems Consultants, LLC1999-06-09
NEUROMAP (K981820)Radionics, Inc.1998-11-20
PALI-TRODE (K981015)Preferred Instruments1998-06-16
AD-TECH'S SPINAL ELECTRODE (K973454)Ad-Tech Medical Instrument Corp1998-06-10
GUIDELINE SYSTEM (K970943)Axon Instruments, Inc.1997-08-18
AD-TECH'S DEPTH ELECTRODE (K964644)Ad-Tech Medical Instrument Corp1997-05-09
PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX) (K970418)Pmt Corp.1997-04-29
TENS-IT, FITTRONIC II, (MORE LATER) (K946018)Ems, Inc.1995-11-09
CUEVA CRANIAL NERVE ELECTRODE (K944061)Ad-Tech Medical Instrument Corp1995-01-20
MEDI MODEL SBL502-B (LISS BODY STIMULATOR) ZERO DC (K902976)Medical Consultants Intl. , Ltd.1990-09-07
AD-TECH'S DEPTH ELECTRODE (K891920)Ad-Tech Medical Instrument Corp1989-07-27
WYLER SPHENOIDAL ELECTRODE (K861031)Ad-Tech Medical Instrument Corp1986-08-25
MICROLET FAMILY OF NEEDLE/DEPTH ELECT- (K802249)Progress Mankind Technology1980-11-19
PMT DEPTHALON DEPTH #2102 (K802152)Progress Mankind Technology1980-11-19
PMT DEPTHALON DEPTH CORTICOGRAPHY ELEC (K802151)Progress Mankind Technology1980-11-19

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