Atlas FDA

GXZ

53 FDA 510(k) clearances · Product code

140 daysmedian time to decision
414 days90th percentile
53clearances measured

FDA profile

Official device name
Electrode, Needle
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1350
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
2019: 14 · 2022: 18 · 2023: 21 · 2024: 58 · 2025: 76 · 2026: 19
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
Disposable Subdermal Needle Electrode, Corkscrew (K241045)Technomed Europe2024-12-11
Medical Disposable Sterile Needle Electrode (K232581)Suzhou Haishen Medical Device Associates Co., Ltd.2023-12-04
Phantom XL Insulated Dilators (K231691)TeDan Surgical Innovations, Inc.2023-06-29
Guardian Needle Electrode (K200984)Rhythmlink International, LLC2020-05-27
Spes Medica Subdermal Needle Electrodes (K192603)Spes Medica Srl2019-11-22
PressOn Electrode Headset (K190801)Rhythmlink International, LLC2019-07-10
DMS Disposable Subdermal Needle Electrodes (K161566)Daehan Medical Systems Co., Ltd.2016-12-21
E-Shield Multi-paried Subdermal Needle Electrodes (K142470)Neuroinvent, Inc.2014-11-05
E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES (K140200)Neuroinvent, Inc.2014-07-18
MR CONDITIONAL PRESSON ELECTRODE (K130220)Rhythmlink International, LLC2013-07-22
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, (K130136)Technomed Europe2013-07-19
PRESSON ELECTRODE (K121347)Rhythmlink International, LLC2012-07-12
PRESSON ELECTRODE (K103103)Persyst Development Corp.2011-12-08
AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS (K110419)Stryker Spine2011-07-28
DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE (K100912)Kirwan Surgical Products, Inc.2010-08-19
NERVE MONITORING CABLE (K073229)Pioneer Surgical Technology2008-06-06
SUBDERMAL NEEDLE ELECTRODES (K072276)Xian Friendship Electronics Co., Ltd.2008-05-16
DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 (K063729)Technomed Europe2007-08-21
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE (K071185)Ambu A/S2007-05-30
DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES (K062996)Axon Systems, Inc.2007-01-12
SUBDERMAL WIRE ELECTRODE, MODEL SWE (K062880)Ives Eeg Solutions, Inc.2006-12-22
PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE) (K060189)Ives Eeg Solutions, Inc.2006-05-30
XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 (K052111)Excel Tech. , Ltd.2005-08-17
DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE (K050325)Technomed Europe2005-05-05
AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES (K050194)Axon Systems, Inc.2005-04-26
ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE (K040639)Isurgical2004-05-21
LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812 (K023472)Class A Enterprises, Inc.2003-03-18
RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES (K022914)Rhythmlink International, LLC2002-12-20
SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF (K020910)The Electrode Store, Inc.2002-07-19
DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570 (K021118)Class A Ent.2002-05-28
STERILE SUBDERMAL NEEDLE ELECTRODES (K010019)Nicolet Biomedical, Inc.2001-03-19
POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE (K990100)Te ME NA S.A.R.L.2000-08-02
ACCUGUIDE MUSCLE INJECTION MONITOR (K990793)Medtronic Xomed1999-10-22
NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES (K983597)Medicotest, Inc.1999-01-11
DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM) (K974119)Jack'S Electrodes1998-01-28
DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) (K950314)Dantec Medical, Inc.1996-03-25
PROTECTRODE SYSTEM (K926094)The Electrode Store, Inc.1995-12-06
AGRAM SPYRAL ELECTRODE (K934779)Agram Export-Import Co.1995-03-14
EEG NEEDLE ELECTRODE (K933796)Cadwell Laboratories, Inc.1994-12-29
CONCENTRIC EMG NEEDLE ELECTRODE (K933795)Cadwell Laboratories, Inc.1994-04-22
MONOPOLAR EMG NEEDLE ELECTRODE (K933806)Cadwell Laboratories, Inc.1994-04-22
GROUND/REFERENCE NEEDLE ELECTRODE (K933793)Cadwell Laboratories, Inc.1994-04-19
PROBLOC INSULATED NEEDLES (K926349)Life-Tech Intl., Inc.1993-07-29
BIO-DETEK EEG ELECTRODE (K920352)Bio-Detek, Inc.1992-08-14
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE (K912783)Class A Ent.1992-02-05
SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118 (K894911)Dantec Electronics, Inc.1990-05-14
SPECIMEX DC (K900740)Soredex Medical Systems1990-05-11
DISPOSIBLE EEG NEEDLE ELECTRODES (K901280)Medicotest, Inc.1990-05-11
DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45) (K896370)Chalgren Enterprises, Inc.1989-12-22
LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP) (K863135)Neurotechnics, Inc.1987-09-04
HIGH PROFILE NEEDLE ELECTRODE (N-SPYRAL HP) (K863136)Neurotechnics, Inc.1987-09-04
CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE (K850107)Nicolet Biomedical Instruments1985-04-11
ELECTRODE, NEEDLE, CFM (K781311)Applied Medical Research1978-08-21

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