Home / Device Classification / GXZ

GXZ — Electrode, Needle Class II

FDA Device Classification

Classification Details

Product Code
GXZ
Device Class
Class II
Regulation Number
882.1350
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241045technomed europeDisposable Subdermal Needle Electrode, CorkscrewDecember 11, 2024
K232581suzhou haishen medical device associates coMedical Disposable Sterile Needle ElectrodeDecember 4, 2023
K231691tedan surgical innovationsPhantom XL Insulated DilatorsJune 29, 2023
K200984rhythmlink internationalGuardian Needle ElectrodeMay 27, 2020
K192603spes medicaSpes Medica Subdermal Needle ElectrodesNovember 22, 2019
K190801rhythmlink internationalPressOn Electrode HeadsetJuly 10, 2019
K161566daehan medical systems coDMS Disposable Subdermal Needle ElectrodesDecember 21, 2016
K142470neuroinventE-Shield Multi-paried Subdermal Needle ElectrodesNovember 5, 2014
K140200neuroinventE-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODESJuly 18, 2014
K130220rhythmlink internationalMR CONDITIONAL PRESSON ELECTRODEJuly 22, 2013
K130136technomed europeDISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBJuly 19, 2013
K121347rhythmlink internationalPRESSON ELECTRODEJuly 12, 2012
K103103persyst developmentPRESSON ELECTRODEDecember 8, 2011
K110419stryker spineAVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORSJuly 28, 2011
K100912kirwan surgical productsDISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULAAugust 19, 2010
K073229pioneer surgical technologyNERVE MONITORING CABLEJune 6, 2008
K072276xian friendship electronics coSUBDERMAL NEEDLE ELECTRODESMay 16, 2008
K063729technomed europeDISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00August 21, 2007
K071185ambuMODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODEMay 30, 2007
K062996axon systemsDISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBESJanuary 12, 2007