FDA 510(k) Applications for Medical Device Product Code "GXZ"
(Electrode, Needle)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K071185 | AMBU A/S | MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE | 05/30/2007 |
| K050194 | AXON SYSTEMS, INC. | AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES | 04/26/2005 |
| K062996 | AXON SYSTEMS, INC. | DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES | 01/12/2007 |
| K021118 | CLASS A ENT. | DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570 | 05/28/2002 |
| K023472 | CLASS A ENTERPRISES, INC. | LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812 | 03/18/2003 |
| K161566 | Daehan Medical Systems Co., Ltd. | DMS Disposable Subdermal Needle Electrodes | 12/21/2016 |
| K950314 | DANTEC MEDICAL, INC. | DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) | 03/25/1996 |
| K052111 | EXCEL TECH. LTD. | XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 | 08/17/2005 |
| K040639 | ISURGICAL | ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE | 05/21/2004 |
| K060189 | IVES EEG SOLUTIONS, INC. | PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE) | 05/30/2006 |
| K062880 | IVES EEG SOLUTIONS, INC. | SUBDERMAL WIRE ELECTRODE, MODEL SWE | 12/22/2006 |
| K974119 | JACK'S ELECTRODES | DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM) | 01/28/1998 |
| K100912 | KIRWAN SURGICAL PRODUCTS, INC. | DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE | 08/19/2010 |
| K983597 | MEDICOTEST, INC. | NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES | 01/11/1999 |
| K990793 | MEDTRONIC XOMED | ACCUGUIDE MUSCLE INJECTION MONITOR | 10/22/1999 |
| K140200 | NEUROINVENT INC. | E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES | 07/18/2014 |
| K142470 | NEUROINVENT INC. | E-Shield Multi-paried Subdermal Needle Electrodes | 11/05/2014 |
| K010019 | NICOLET BIOMEDICAL, INC. | STERILE SUBDERMAL NEEDLE ELECTRODES | 03/19/2001 |
| K103103 | PERSYST DEVELOPMENT CORP. | PRESSON ELECTRODE | 12/08/2011 |
| K073229 | PIONEER SURGICAL TECHNOLOGY | NERVE MONITORING CABLE | 06/06/2008 |
| K200984 | Rhythmlink International, LLC | Guardian Needle Electrode | 05/27/2020 |
| K130220 | RHYTHMLINK INTERNATIONAL, LLC | MR CONDITIONAL PRESSON ELECTRODE | 07/22/2013 |
| K121347 | RHYTHMLINK INTERNATIONAL, LLC | PRESSON ELECTRODE | 07/12/2012 |
| K190801 | Rhythmlink International, LLC | PressOn Electrode Headset | 07/10/2019 |
| K022914 | RHYTHMLINK INTERNATIONAL, LLC | RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES | 12/20/2002 |
| K192603 | Spes Medica S.r.l. | Spes Medica Subdermal Needle Electrodes | 11/22/2019 |
| K110419 | STRYKER SPINE | AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS | 07/28/2011 |
| K990100 | TE ME NA S.A.R.L. | POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE | 08/02/2000 |
| K130136 | TECHNOMED EUROPE | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, | 07/19/2013 |
| K050325 | TECHNOMED EUROPE | DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE | 05/05/2005 |
| K063729 | TECHNOMED EUROPE | DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 | 08/21/2007 |
| K231691 | TeDan Surgical Innovations Inc. | Phantom XL Insulated Dilators | 06/29/2023 |
| K020910 | THE ELECTRODE STORE, INC. | SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF | 07/19/2002 |
| K072276 | XIAN FRIENDSHIP ELECTRONICS CO.,LTD. | SUBDERMAL NEEDLE ELECTRODES | 05/16/2008 |
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