FDA Product Code
FDA Product Code GXZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1350
510(k) Clearances — 53 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241045 | Disposable Subdermal Needle Electrode, Corkscrew | Technomed Europe | 2024-12-11 | Traditional | PDF ↗ |
| K232581 | Medical Disposable Sterile Needle Electrode | Suzhou Haishen Medical Device Associates Co., Ltd. | 2023-12-04 | Traditional | PDF ↗ |
| K231691 | Phantom XL Insulated Dilators | TeDan Surgical Innovations, Inc. | 2023-06-29 | Special | PDF ↗ |
| K200984 | Guardian Needle Electrode | Rhythmlink International, LLC | 2020-05-27 | Special | PDF ↗ |
| K192603 | Spes Medica Subdermal Needle Electrodes | Spes Medica Srl | 2019-11-22 | Traditional | PDF ↗ |
| K190801 | PressOn Electrode Headset | Rhythmlink International, LLC | 2019-07-10 | Traditional | PDF ↗ |
| K161566 | DMS Disposable Subdermal Needle Electrodes | Daehan Medical Systems Co., Ltd. | 2016-12-21 | Traditional | PDF ↗ |
| K142470 | E-Shield Multi-paried Subdermal Needle Electrodes | Neuroinvent, Inc. | 2014-11-05 | Special | PDF ↗ |
| K140200 | E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES | Neuroinvent, Inc. | 2014-07-18 | Traditional | PDF ↗ |
| K130220 | MR CONDITIONAL PRESSON ELECTRODE | Rhythmlink International, LLC | 2013-07-22 | Traditional | PDF ↗ |
| K130136 | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, | Technomed Europe | 2013-07-19 | Traditional | PDF ↗ |
| K121347 | PRESSON ELECTRODE | Rhythmlink International, LLC | 2012-07-12 | Traditional | PDF ↗ |
| K103103 | PRESSON ELECTRODE | Persyst Development Corp. | 2011-12-08 | Traditional | PDF ↗ |
| K110419 | AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS | Stryker Spine | 2011-07-28 | Traditional | PDF ↗ |
| K100912 | DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE | Kirwan Surgical Products, Inc. | 2010-08-19 | Traditional | PDF ↗ |
| K073229 | NERVE MONITORING CABLE | Pioneer Surgical Technology | 2008-06-06 | Abbreviated | PDF ↗ |
| K072276 | SUBDERMAL NEEDLE ELECTRODES | Xian Friendship Electronics Co., Ltd. | 2008-05-16 | Traditional | PDF ↗ |
| K063729 | DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 | Technomed Europe | 2007-08-21 | Traditional | PDF ↗ |
| K071185 | MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE | Ambu A/S | 2007-05-30 | Special | PDF ↗ |
| K062996 | DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES | Axon Systems, Inc. | 2007-01-12 | Traditional | PDF ↗ |
| K062880 | SUBDERMAL WIRE ELECTRODE, MODEL SWE | Ives Eeg Solutions, Inc. | 2006-12-22 | Traditional | PDF ↗ |
| K060189 | PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE) | Ives Eeg Solutions, Inc. | 2006-05-30 | Traditional | PDF ↗ |
| K052111 | XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 | Excel Tech. , Ltd. | 2005-08-17 | Abbreviated | PDF ↗ |
| K050325 | DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE | Technomed Europe | 2005-05-05 | Traditional | PDF ↗ |
| K050194 | AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES | Axon Systems, Inc. | 2005-04-26 | Traditional | PDF ↗ |
| K040639 | ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE | Isurgical | 2004-05-21 | Traditional | PDF ↗ |
| K023472 | LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812 | Class A Enterprises, Inc. | 2003-03-18 | Traditional | PDF ↗ |
| K022914 | RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES | Rhythmlink International, LLC | 2002-12-20 | Traditional | PDF ↗ |
| K020910 | SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF | The Electrode Store, Inc. | 2002-07-19 | Traditional | PDF ↗ |
| K021118 | DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570 | Class A Ent. | 2002-05-28 | Special | PDF ↗ |
| K010019 | STERILE SUBDERMAL NEEDLE ELECTRODES | Nicolet Biomedical, Inc. | 2001-03-19 | Abbreviated | PDF ↗ |
| K990100 | POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE | Te ME NA S.A.R.L. | 2000-08-02 | Traditional | PDF ↗ |
| K990793 | ACCUGUIDE MUSCLE INJECTION MONITOR | Medtronic Xomed | 1999-10-22 | Traditional | PDF ↗ |
| K983597 | NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES | Medicotest, Inc. | 1999-01-11 | Traditional | PDF ↗ |
| K974119 | DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM) | Jack'S Electrodes | 1998-01-28 | Traditional | PDF ↗ |
| K950314 | DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) | Dantec Medical, Inc. | 1996-03-25 | Traditional | PDF ↗ |
| K926094 | PROTECTRODE SYSTEM | The Electrode Store, Inc. | 1995-12-06 | Traditional | PDF ↗ |
| K934779 | AGRAM SPYRAL ELECTRODE | Agram Export-Import Co. | 1995-03-14 | Traditional | PDF ↗ |
| K933796 | EEG NEEDLE ELECTRODE | Cadwell Laboratories, Inc. | 1994-12-29 | Traditional | PDF ↗ |
| K933795 | CONCENTRIC EMG NEEDLE ELECTRODE | Cadwell Laboratories, Inc. | 1994-04-22 | Traditional | PDF ↗ |
| K933806 | MONOPOLAR EMG NEEDLE ELECTRODE | Cadwell Laboratories, Inc. | 1994-04-22 | Traditional | PDF ↗ |
| K933793 | GROUND/REFERENCE NEEDLE ELECTRODE | Cadwell Laboratories, Inc. | 1994-04-19 | Traditional | PDF ↗ |
| K926349 | PROBLOC INSULATED NEEDLES | Life-Tech Intl., Inc. | 1993-07-29 | Traditional | PDF ↗ |
| K920352 | BIO-DETEK EEG ELECTRODE | Bio-Detek, Inc. | 1992-08-14 | Traditional | PDF ↗ |
| K912783 | DISPOSABLE MONOPOLAR NEEDLE ELECTRODE | Class A Ent. | 1992-02-05 | Traditional | PDF ↗ |
| K894911 | SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118 | Dantec Electronics, Inc. | 1990-05-14 | Traditional | PDF ↗ |
| K900740 | SPECIMEX DC | Soredex Medical Systems | 1990-05-11 | Traditional | PDF ↗ |
| K901280 | DISPOSIBLE EEG NEEDLE ELECTRODES | Medicotest, Inc. | 1990-05-11 | Traditional | PDF ↗ |
| K896370 | DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45) | Chalgren Enterprises, Inc. | 1989-12-22 | Traditional | PDF ↗ |
| K863135 | LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP) | Neurotechnics, Inc. | 1987-09-04 | Traditional | PDF ↗ |
| K863136 | HIGH PROFILE NEEDLE ELECTRODE (N-SPYRAL HP) | Neurotechnics, Inc. | 1987-09-04 | Traditional | PDF ↗ |
| K850107 | CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE | Nicolet Biomedical Instruments | 1985-04-11 | Traditional | PDF ↗ |
| K781311 | ELECTRODE, NEEDLE, CFM | Applied Medical Research | 1978-08-21 | Traditional | PDF ↗ |
Product code GXZ · Class II · Neurology. Data: openFDA.