Atlas FDA

GYC

32 FDA 510(k) clearances · Product code

205 daysmedian time to decision
446 days90th percentile
32clearances measured

FDA profile

Official device name
Electrode, Cortical
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1310
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
2007: 2 · 2010: 3 · 2011: 6 · 2012: 17 · 2014: 14 · 2015: 9
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014) (K250094)Neuralynx, Inc.2025-04-14
Layer 7-T (K242618)Precision Neuroscience, Corp.2025-03-30
WISE Cortical Strip (WCS) (K221123)Wise S.R.L.2022-11-22
Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid (K211954)Spes Medica Srl2022-11-10
Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) (K201931)Dixi Medical2021-10-02
Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) (K191346)Blackrock Microsystems2020-02-14
Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode (K191186)Ad-Tech Medical Instrument Corporation2020-01-25
NeuroOne Cortical Electrode (K192764)Neuroone, Inc.2019-11-26
AirRay Subdural Cortical Electrodes (K183437)Cortec GmbH2019-03-12
SD LTM STIM Cortical Stimulator (K180761)Micromed S.P.A.2018-06-18
g.Estim PRO (K173684)G.Tec Medical Engineering GmbH2018-05-04
Cervello STIM (K151354)Blackrock Neuromed2016-01-27
MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) (K110410)Nihon Kohden Corp.2011-08-04
INTEGRA ELECTRODE TUNNELING NEEDLE (K102802)Integra LifeSciences Corporation2010-11-23
S12X WITH ESAX OPTION (K082629)Chatten Associates, Inc.2009-07-01
PMT SUBDURAL CORTICAL ELECTRODES (K082474)Pmt Corp.2009-05-08
NICOLET CORTICAL STIMULATOR (K072964)Cardinal Health, Inc.2008-12-30
AURAGEN CORTICAL SURFACE ELECTRODES (K082250)Integra Neurosciences2008-10-10
DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES (K053363)Ad-Tech Medical Instrument Corp2006-05-30
SUBDURAL STRIP ELECTRODE (K021144)Nicolet Biomedical, Inc.2002-06-24
CORTICAL MAPPING UNIT, MODEL CMU (K992194)Ad-Tech Medical Instrument Corp1999-09-13
EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI (K961942)Radionics, Inc.1997-08-18
AD-TECH SUBDURAL ELECTRODE (K970587)Ad-Tech Medical Instrument Corp1997-05-09
STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE (K964224)Pmt Corp.1997-03-19
CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON (K926424)Radionics, Inc.1993-11-19
THE WESTERN CORTICAL ELECTRODE ARRAY (K923330)University Hospital (London) Development Corp.1993-11-09
OJEMANN CORTICAL STIMULATOR (K924226)Radionics, Inc.1993-04-21
AD-TECH SUB DURAL ELECTRODEDS (K923803)Ad-Tech Medical Instrument Corp1992-10-23
AD-TECH EPIDURAL PEG ELECTRODE (K912760)Ad-Tech Medical Instrument Corp1992-01-15
NICOLET EPIDURAL SPINAL ELECTRODE (K882053)Nicolet Instrument Corp.1988-10-18
ELECTRODE FOR NEUROLOGICAL SURGERY 2111 (K845035)Progress Mankind Technology1985-07-30
WYLER SUBDURAL STRIP ELECTRODE (K850342)Ad-Tech Medical Instrument Corp1985-07-30

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