Electrode, Needle
FDA product code GXZ · Class II (moderate risk) · 21 CFR 882.1350 · Neurology
53510(k) clearances
0PMA approvals
20recalls
Manufacturers
- Rhythmlink International, LLC 5
- Technomed Europe 4
- Cadwell Laboratories, Inc. 4
- Axon Systems, Inc. 2
- Ives Eeg Solutions, Inc. 2
- The Electrode Store, Inc. 2
- Neuroinvent, Inc. 2
- Class A Ent. 2
- Medicotest, Inc. 2
- Neurotechnics, Inc. 2
- Dantec Electronics, Inc. 1
- Life-Tech Intl., Inc. 1
- Agram Export-Import Co. 1
- Soredex Medical Systems 1
- Dantec Medical, Inc. 1
- Jack'S Electrodes 1
- Suzhou Haishen Medical Device Associates Co., Ltd. 1
- Te ME NA S.A.R.L. 1
- Nicolet Biomedical, Inc. 1
- Nicolet Biomedical Instruments 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241045 | Disposable Subdermal Needle Electrode, CorkscrewGXZ · Traditional | Technomed Europe | 12/11/2024SE |
| K232581 | Medical Disposable Sterile Needle ElectrodeGXZ · Traditional | Suzhou Haishen Medical Device Associates Co., Ltd. | 12/04/2023SE |
| K231691 | Phantom XL Insulated DilatorsGXZ · Special | TeDan Surgical Innovations, Inc. | 06/29/2023SE |
| K200984 | Guardian Needle ElectrodeGXZ · Special | Rhythmlink International, LLC | 05/27/2020SE |
| K192603 | Spes Medica Subdermal Needle ElectrodesGXZ · Traditional | Spes Medica Srl | 11/22/2019SE |
| K190801 | PressOn Electrode HeadsetGXZ · Traditional | Rhythmlink International, LLC | 07/10/2019SE |
| K161566 | DMS Disposable Subdermal Needle ElectrodesGXZ · Traditional | Daehan Medical Systems Co., Ltd. | 12/21/2016SE |
| K142470 | E-Shield Multi-paried Subdermal Needle ElectrodesGXZ · Special | Neuroinvent, Inc. | 11/05/2014SE |
| K140200 | E-Shield Multi-Paired Subdermal Needle ElectrodesGXZ · Traditional | Neuroinvent, Inc. | 07/18/2014SE |
| K130220 | MR Conditional Presson ElectrodeGXZ · Traditional | Rhythmlink International, LLC | 07/22/2013SE |
| K130136 | Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…GXZ · Traditional | Technomed Europe | 07/19/2013SE |
| K121347 | Presson ElectrodeGXZ · Traditional | Rhythmlink International, LLC | 07/12/2012SE |
| K103103 | Presson ElectrodeGXZ · Traditional | Persyst Development Corp. | 12/08/2011SE |
| K110419 | Avs Aria Neuromonitoring Probe and Avs Aria Probe DilatorsGXZ · Traditional | Stryker Spine | 07/28/2011SE |
| K100912 | Disposable Nerve Stimulating Probe, Bipolar Concentric, Disposable Nerve Stimulator…GXZ · Traditional | Kirwan Surgical Products, Inc. | 08/19/2010SE |
| K073229 | Nerve Monitoring CableGXZ · Abbreviated | Pioneer Surgical Technology | 06/06/2008SE |
| K072276 | Subdermal Needle ElectrodesGXZ · Traditional | Xian Friendship Electronics Co., Ltd. | 05/16/2008SE |
| K063729 | Disposable Pedicle Screw Probe, Model 3603-00GXZ · Traditional | Technomed Europe | 08/21/2007SE |
| K071185 | Modification to: Ambu Neuroline, Disposable Monopolar Needle ElectrodeGXZ · Special | Ambu A/S | 05/30/2007SE |
| K062996 | Disposable Monopolar and Bipolar Stimulator ProbesGXZ · Traditional | Axon Systems, Inc. | 01/12/2007SE |
| K062880 | Subdermal Wire Electrode, Model SweGXZ · Traditional | Ives Eeg Solutions, Inc. | 12/22/2006SE |
| K060189 | Pediatric Subdermal Wire Electrode (Pswe)GXZ · Traditional | Ives Eeg Solutions, Inc. | 05/30/2006SE |
| K052111 | Xltek Clear Signal Sub-Dermal Needle, Models 102889, 102798, 102799, 102382GXZ · Abbreviated | Excel Tech. , Ltd. | 08/17/2005SE |
| K050325 | Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar ProbeGXZ · Traditional | Technomed Europe | 05/05/2005SE |
| K050194 | Axon Systems Subdermal Needle ElectrodesGXZ · Traditional | Axon Systems, Inc. | 04/26/2005SE |
| K040639 | Isurg Disposable Subdermal Needle ElectrodeGXZ · Traditional | Isurgical | 05/21/2004SE |
| K023472 | Low Profile EEG Needle Electrode, Models 112-812-18TP, 112-812-48TP, 112-812-60TP…GXZ · Traditional | Class A Enterprises, Inc. | 03/18/2003SE |
| K022914 | Rhythmlink International Subdermal Needle ElectrodesGXZ · Traditional | Rhythmlink International, LLC | 12/20/2002SE |
| K020910 | Subdermal Needle Electrode for Electroencephalography, Models PRO-E12SAF and DEN-12SAFGXZ · Traditional | The Electrode Store, Inc. | 07/19/2002SE |
| K021118 | Detachable Monopolar Emg Needle, Models 610-725, 610-737, 610-637, 610-744, 610-650…GXZ · Special | Class A Ent. | 05/28/2002SE |
| K010019 | Sterile Subdermal Needle ElectrodesGXZ · Abbreviated | Nicolet Biomedical, Inc. | 03/19/2001SE |
| K990100 | Polymedic Upa Nerve Stimulation Needle; Polymedic Upc Nerve Stimulation NeedleGXZ · Traditional | Te ME NA S.A.R.L. | 08/02/2000SE |
| K990793 | Accuguide Muscle Injection MonitorGXZ · Traditional | Medtronic Xomed | 10/22/1999SE |
| K983597 | Neuroline, Disposable Monopolar Needle ElectrodesGXZ · Traditional | Medicotest, Inc. | 01/11/1999SE |
| K974119 | Disposable Needle Electrode (Alm), Disposable Needle Electrode (DLM)GXZ · Traditional | Jack'S Electrodes | 01/28/1998SE |
| K950314 | Dantec Monopolar Lumen Electrode (13R18 and 13R19)GXZ · Traditional | Dantec Medical, Inc. | 03/25/1996SE |
| K926094 | Protectrode SystemGXZ · Traditional | The Electrode Store, Inc. | 12/06/1995SE |
| K934779 | Agram Spyral ElectrodeGXZ · Traditional | Agram Export-Import Co. | 03/14/1995SE |
| K933796 | EEG Needle ElectrodeGXZ · Traditional | Cadwell Laboratories, Inc. | 12/29/1994SE |
| K933806 | Monopolar Emg Needle ElectrodeGXZ · Traditional | Cadwell Laboratories, Inc. | 04/22/1994SE |
| K933795 | Concentric Emg Needle ElectrodeGXZ · Traditional | Cadwell Laboratories, Inc. | 04/22/1994SE |
| K933793 | Ground/Reference Needle ElectrodeGXZ · Traditional | Cadwell Laboratories, Inc. | 04/19/1994SE |
| K926349 | Probloc Insulated NeedlesGXZ · Traditional | Life-Tech Intl., Inc. | 07/29/1993SE |
| K920352 | Bio-Detek EEG ElectrodeGXZ · Traditional | Bio-Detek, Inc. | 08/14/1992SE |
| K912783 | Disposable Monopolar Needle ElectrodeGXZ · Traditional | Class A Ent. | 02/05/1992SE |
| K894911 | Sensory Needle Electrode Dne 111-115,116-117,118GXZ · Traditional | Dantec Electronics, Inc. | 05/14/1990SE |
| K901280 | Disposible EEG Needle ElectrodesGXZ · Traditional | Medicotest, Inc. | 05/11/1990SE |
| K900740 | Specimex DCGXZ · Traditional | Soredex Medical Systems | 05/11/1990SE |
| K896370 | Disp. Concentric Needle Electrode (DCP-30, DCP-45)GXZ · Traditional | Chalgren Enterprises, Inc. | 12/22/1989SE |
| K863136 | High Profile Needle Electrode (N-Spyral HP)GXZ · Traditional | Neurotechnics, Inc. | 09/04/1987SE |
| K863135 | Low Profile Needle Electrode (N-Spyral LP)GXZ · Traditional | Neurotechnics, Inc. | 09/04/1987SE |
| K850107 | Concentric Needle Electrodes-Various Sizes W/ConneGXZ · Traditional | Nicolet Biomedical Instruments | 04/11/1985SE |
| K781311 | Electrode, Needle, CFMGXZ · Traditional | Applied Medical Research | 08/21/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0465-2022 Class II | Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers…There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining… | Technomed Europe | 12/08/2021Terminated |
| Z-2379-2010 | 24G x 25mm/45 Bevel Single Shot Needle, REF 554-024-025, Rx, Sterile, Distributed by:…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | Stryker Instruments Div. of Stryker… | 02/01/2010Terminated |
| Z-2378-2010 | 22G x 70mm/45 Bevel Single Shot Needle, REF 554-022-070, Rx, Sterile, Distributed by:…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | Stryker Instruments Div. of Stryker… | 02/01/2010Terminated |
| Z-2377-2010 | 22G x 50mm/45 Bevel Single Shot Needle, REF 554-022-050, Rx, Sterile, Distributed by:…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | Stryker Instruments Div. of Stryker… | 02/01/2010Terminated |
| Z-2376-2010 | 21G x 150mm Stimulation Catheter Continuous Nerve Block Tray, REF 554-021-150, Rx…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | Stryker Instruments Div. of Stryker… | 02/01/2010Terminated |
| Z-2375-2010 | 21G x 90mm/45 Bevel Single Shot Needle, REF 554-021-090, Rx, Sterile, Distributed by:…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | Stryker Instruments Div. of Stryker… | 02/01/2010Terminated |
| Z-2374-2010 | 17G x 150mm Stimulation Catheter Continuous Nerve Block Tray, REF 553-318-150, Rx…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | Stryker Instruments Div. of Stryker… | 02/01/2010Terminated |
| Z-2373-2010 | 17G x 90mm Stimulation Catheter Continuous Nerve Block Tray, REF 553-318-090, Rx…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | Stryker Instruments Div. of Stryker… | 02/01/2010Terminated |
| Z-2372-2010 | 17G x 150mm Stimulation Catheter Continuous Nerve Block Tray, REF 553-318-050, Rx…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | Stryker Instruments Div. of Stryker… | 02/01/2010Terminated |
| Z-2371-2010 | 17G x 150mm Tuohy Stimulation Catheter Kit, REF 553-218-150, Rx, Sterile, Distributed…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | Stryker Instruments Div. of Stryker… | 02/01/2010Terminated |
| Z-2370-2010 | 17G x 90m Tuohy Stimulation Catheter Kit, REF 553-218-90, Rx, Sterile, Distributed by:…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | Stryker Instruments Div. of Stryker… | 02/01/2010Terminated |
| Z-2369-2010 | 17G x 50m Tuohy Catheter Kit, REF 553-218-50, Rx, Sterile, Distributed by: Stryker…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | Stryker Instruments Div. of Stryker… | 02/01/2010Terminated |
| Z-2368-2010 | 18G x 150m Tuohy Catheter Kit, REF 553-118-150, Rx, Sterile, Distributed by: Stryker…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | Stryker Instruments Div. of Stryker… | 02/01/2010Terminated |
| Z-2367-2010 | 18G x 90mm/20 Tuohy Catheter Kit, REF 553-118-090, Rx, Sterile, Distributed by: Stryker…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | Stryker Instruments Div. of Stryker… | 02/01/2010Terminated |
| Z-2366-2010 | 18G x 50mm/20 Tuohy Catheter Kit, REF 553-118-050, Rx, Sterile, Distributed by: Stryker…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | Stryker Instruments Div. of Stryker… | 02/01/2010Terminated |
| Z-2365-2010 | 24G x 25mm/20 bevel Single Shot Needle, REF 552-024-025, Rx, Sterile, Distributed by:…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | Stryker Instruments Div. of Stryker… | 02/01/2010Terminated |
| Z-2364-2010 | 22G x 70mm/20 bevel Single Shot Needle, REF 552-022-70, Rx, Sterile, Distributed by:…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | Stryker Instruments Div. of Stryker… | 02/01/2010Terminated |
| Z-2363-2010 | 21G x 150m/20 bevel Single Shot Needle, REF 552-021-150, Rx, Sterile, Distributed by:…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | Stryker Instruments Div. of Stryker… | 02/01/2010Terminated |
| Z-2362-2010 | 22G x 50m/20 bevel Single Shot Needle, REF 552-022-050, Rx, Sterile, Distributed by:…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | Stryker Instruments Div. of Stryker… | 02/01/2010Terminated |
| Z-2361-2010 | 21G x 90mm/20 Bevel Single Shot Needle, REF 55-021-090, Rx, Sterile, Distributed by:…Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective… | Stryker Instruments Div. of Stryker… | 02/01/2010Terminated |