Stimulator, Nerve
FDA product code ETN · Class II (moderate risk) · 21 CFR 874.1820 · Ear, Nose, Throat
97510(k) clearances
0PMA approvals
30recalls
Manufacturers
- Medtronic Xomed, Inc. 10
- The Magstim Company , Ltd. 9
- Nuvasive, Inc. 6
- Rln Systems, Inc. 5
- Inomed Medizintechnik GmbH 5
- Neurovision Medical Products Inc 5
- Uromed Corp. 3
- Ndi Medical, LLC 3
- Baxano, Inc. 3
- Rhythmlink International, LLC 2
- Wr Medical Electronics Co. 2
- Aaron Medical Industries 2
- Xomed-Treace, Inc. 2
- Spes Medica Srl 2
- Technomed Europe 2
- Xomed, Inc. 2
- Downs Surgical , Ltd. 1
- Porex Medical 1
- Epineuron Technologies, Inc. 1
- Life-Tech Intl., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253536 | Evala Nerve Stimulator (EPNR002)ETN · Traditional | Epineuron Technologies, Inc. | 02/27/2026SE |
| K251672 | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube…ETN · Traditional | Medtronic Xomed, Inc. | 02/10/2026SE |
| K242852 | ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube…ETN · Traditional | Inomed Medizintechnik GmbH | 06/13/2025SE |
| K233001 | Bioscope Neuromonitor DeviceETN · Traditional | Biosys Biyomedikal Muhendislik San. VE Tic. A.S. | 12/13/2024SE |
| K241917 | EARP Nerve Cuff ElectrodeETN · Special | Retropsoas Technologies, LLC | 07/31/2024SE |
| K232888 | Disposable Laryngeal ElectrodesETN · Traditional | Suzhou Haishen Medical Device Associates Co., Ltd. | 12/21/2023SE |
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal TubeETN · Special | Medtronic Xomed, Inc. | 10/26/2023SE |
| K230853 | EARP Nerve Cuff ElectrodeETN · Traditional | Nvision Biomedical Technologies, Inc. | 10/06/2023SE |
| K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)ETN · Traditional | Medtronic Xomed, Inc. | 08/30/2023SE |
| K223254 | C2 XploreETN · Traditional | Inomed Medizintechnik GmbH | 01/27/2023SE |
| K212164 | Mapping Suction ProbeETN · Traditional | Inomed Medizintechnik GmbH | 11/11/2022SE |
| K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM…ETN · Traditional | Medtronic Xomed, Inc. | 03/21/2022SE |
| K212355 | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative…ETN · Special | Checkpoint Surgical | 08/26/2021SE |
| K200886 | StimSiteETN · Traditional | Allotrope Medical, Inc. | 11/10/2020SE |
| K152769 | Fremap ElectrodeETN · Traditional | Ad-Tech Medical Instrument Corporation | 05/06/2016SE |
| K152505 | C2 NerveMonitor SystemETN · Traditional | Inomed Medizintechnik GmbH | 02/01/2016SE |
| K150005 | Checkpoint, Checkpoint Head & NeckETN · Special | Ndi Medical, LLC | 02/19/2015SE |
| K133348 | Stim ProbeETN · Traditional | Spes Medica Srl | 11/21/2014SE |
| K140400 | ES2 Neuromonitoring Accessory InstrumentsETN · Traditional | Stryker Corporation | 07/01/2014SE |
| K122040 | Invotec Laryngeal ElectrodeETN · Traditional | Invotec International, Inc. | 10/31/2013SE |
| K121931 | Nondisposable Stimulating InstrumentsETN · Traditional | Neurovision Medical Products, Inc. | 10/19/2012SE |
| K121257 | Laryngeal ElectrodeETN · Traditional | Technomed Europe | 08/28/2012SE |
| K112686 | Next Gen Emg Endotracheal TubeETN · Traditional | Medtronic Xomed, Inc. | 06/27/2012SE |
| K112717 | Nuvasive Nvjjb SystemETN · Traditional | Nuvasive, Inc. | 04/13/2012SE |
| K112426 | Xian Friendship Disposable Nerve Stimulator ProbesETN · Traditional | Xian Friendship Medical Electronics Co., Ltd. | 04/02/2012SE |
| K112718 | Nuvasive NVM5 SystemETN · Traditional | Nuvasive, Inc. | 03/16/2012SE |
| K112709 | Stimulation/Dissection InstrumentsETN · Traditional | Nu Vasive, Incorporated | 02/09/2012SE |
| K111671 | Seaspine Monopolar Probe SysyemETN · Traditional | Seaspine, Inc. | 12/28/2011SE |
| K110989 | Neurovision Ink Printed Endotracheal Tube ElectrodeETN · Traditional | Neurovision Medical Products, Inc. | 11/03/2011SE |
| K111597 | Disposable Stimulating ElectrodeETN · Traditional | Nuvasive, Inc. | 10/13/2011SE |
| K112435 | Rhythmlink Monopolar Stimulating InstrumentETN · Special | Rhythmlink International, LLC | 09/22/2011SE |
| K110696 | Neuro Check Device with Io-Flex WireETN · Traditional | Baxano, Inc. | 07/07/2011SE |
| K110712 | Drytouch Suction Stimulator ProbeETN · Traditional | Neurovision Medical Products, Inc. | 06/28/2011SE |
| K110422 | Surgical StimulatorsETN · Traditional | Technomed Europe | 05/26/2011SE |
| K110138 | Paired Hydrogel ElectrodeETN · Special | Neurovision Medical Products, Inc. | 04/08/2011SE |
| K103128 | Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw…ETN · Traditional | Cadwell Lab, Inc. | 02/23/2011SE |
| K102862 | Neurovision Se (Nerveana)ETN · Traditional | Neurovision Medical Products, Inc. | 12/21/2010SE |
| K100992 | NeuralmasETN · Traditional | Innovative Surgical Solutions, LLC ("Iss") | 09/24/2010SE |
| K093373 | Laryngeal Surface ElectrodeETN · Traditional | Spes Medica Srl | 08/24/2010SE |
| K091874 | Inomed Adhesive Laryngeal Electrodes, Models 530655, 530656ETN · Traditional | Inomed Medizintechnik GmbH | 11/18/2009SE |
| K092292 | CheckpointETN · Traditional | Ndi Medical, LLC | 10/28/2009SE |
| K092729 | Baxano Neuro Check DeviceETN · Special | Baxano, Inc. | 10/02/2009SE |
| K083242 | Neurosign Avalanche Motor Nerve MonitorETN · Traditional | The Magstim Company , Ltd. | 07/29/2009SE |
| K090838 | Stimulus/Dissection InstrumentsETN · Traditional | Axon Systems, Inc. | 07/20/2009SE |
| K081742 | Baxano Neural Localization Probe 1.75 and 1.25ETN · Traditional | Baxano, Inc. | 09/17/2008SE |
| K072736 | Rhythmlink International Monopolar Stimulating InstrumentETN · Traditional | Rhythmlink International, LLC | 01/22/2008SE |
| K071349 | Neurosign Laryngeal ElectrodesETN · Traditional | The Magstim Company , Ltd. | 12/12/2007SE |
| K063560 | Hilger Dual-Stim Nerve StimulatorETN · Abbreviated | Wr Medical Electronics Co. | 01/05/2007SE |
| K063305 | Stimulating Bur GuardETN · Traditional | Medtronic Xomed, Inc. | 11/29/2006SE |
| K062549 | Xltek Stimulator Probes, Models 105233, 105234, 105235, 105236, 105237 and 105238ETN · Traditional | Excel Tech. , Ltd. | 10/04/2006SE |
| K061365 | Checkpoint with Accustim TechnologyETN · Traditional | Ndi Medical, LLC | 07/12/2006SE |
| K053141 | Neurosign Motor Nerve Monitor, Models Neurosign 400 & 800ETN · Special | The Magstim Company , Ltd. | 12/14/2005SE |
| K051718 | Nuvasive Neurovision JJB SystemETN · Traditional | Nuvasive, Inc. | 09/15/2005SE |
| K050162 | Contact Emg Rotatable Endotracheal TubeETN · Traditional | Medtronic Xomed, Inc. | 03/03/2005SE |
| K040543 | Nuvasive Neurovision JJB SystemETN · Special | Nuvasive, Inc. | 04/01/2004SE |
| K032083 | Nuvasive Neurovision JJB SystemETN · Traditional | Nuvasive, Inc. | 10/24/2003SE |
| K031510 | Nim-SpineETN · Traditional | Medtronic Xomed | 06/18/2003SE |
| K031003 | Stimulus/Dissection Instruments, Ball-Tip ProbesETN · Special | Medtronic Xomed, Inc. | 04/11/2003SE |
| K021595 | Gyrus ENT Nerve StimulatorETN · Traditional | Gyrus Ent LLC | 10/24/2002SE |
| K020955 | Nicolet Electrocautery DetectorETN · Abbreviated | Nicolet Biomedical, Inc. | 04/17/2002SE |
| K014165 | Stimulus - Dissection InstrumentsETN · Traditional | Medtronic Xomed, Inc. | 01/22/2002SE |
| K010213 | Modification to Cavermap Surgical AidETN · Traditional | Uromed Corp. | 04/20/2001SE |
| K003745 | Laryngeal Surface Electrode-Endotracheal Tube, M-500-ET, Lse-EtETN · Traditional | Rln Systems, Inc. | 01/16/2001SE |
| K000507 | Cavermap Surgical AidETN · Traditional | Uromed Corp. | 04/21/2000SE |
| K992869 | Xomed Ball-Tip Monopolar Stimulator ProbeETN · Traditional | Xomed, Inc. | 10/07/1999SE |
| K991583 | Neurosign 400, 4 Channel Motor Nerve MonitorETN · Special | The Magstim Company , Ltd. | 05/19/1999SE |
| K982595 | NIM4ETN · Traditional | Xomed, Inc. | 09/04/1998SE |
| K980148 | Neurosign 800, 8 Channel Motor Nerve MonitorETN · Traditional | The Magstim Company , Ltd. | 08/05/1998SE |
| K970971 | Uro Med Nerve StimulatorETN · Traditional | Uromed Corp. | 10/27/1997SE |
| K971143 | Neuro Pulse Ii,IiiETN · Traditional | Aaron Medical Industries | 06/06/1997SE |
| K964869 | Neurosign 800, 8 Channel Motor Nerve MonitorETN · Traditional | The Magstim Company , Ltd. | 05/14/1997SE |
| K954601 | Nerve Locator/Monitor System ModificationETN · Traditional | Rln Systems, Inc. | 12/22/1995SE |
| K945799 | Neurosign 100 Impedance MeterETN · Traditional | The Magstim Company , Ltd. | 06/02/1995SE |
| K951641 | Neuroscreen Software for Use with the Neurosign 100 Nerve MonitorETN · Traditional | The Magstim Company , Ltd. | 05/09/1995SE |
| K945242 | Nerve Monitor Electrodes/Stimulator ProbesETN · Traditional | Micromed Development Corp. | 12/27/1994SE |
| K934733 | Stimulating Surgical InstrumentsETN · Traditional | Smith & Nephew Richards, Inc. | 07/20/1994SE |
| K934426 | Nerve Integrity MONITOR-2 (NIM-2 XL)ETN · Traditional | Xomed-Treace, Inc. | 05/13/1994SE |
| K933491 | R and D Batteries, Inc. Part Nos. 5038 & 5347ETN · Traditional | R & D Batteries, Inc. | 11/19/1993SE |
| K925640 | Xomed-Treace Emg Endotracheal TubeenETN · Traditional | Xomed-Treace, Inc. | 08/17/1993SE |
| K925008 | RLN Nerve Locator/Monitor; Model aETN · Traditional | Rln Systems, Inc. | 11/24/1992SE |
| K923056 | Neurosign Model 100ETN · Traditional | The Magstim Company , Ltd. | 11/24/1992SE |
| K912508 | Nerve Locator/Monitor System, ModificationETN · Traditional | Rln Systems, Inc. | 09/30/1992SE |
| K905035 | Axostim Nerve Stimulator, ModificationETN · Traditional | Singer Medical Products, Inc. | 04/19/1991SE |
| K905045 | Nerve Locator/StimulatorETN · Traditional | Aaron Medical Industries | 03/15/1991SE |
| K895838 | Brackmann Emg Monitoring SystemETN · Traditional | Wr Medical Electronics Co. | 03/27/1990SE |
| K894930 | Dentec 4000ETN · Traditional | Dentec, Inc. | 03/27/1990SE |
| K895676 | Hemostat/Stimulator ProbeETN · Traditional | Rln Systems, Inc. | 12/08/1989SE |
| K881757 | Resubmitted Juniper T.M. Joint Distraction ForcepsETN · Traditional | Downs Surgical , Ltd. | 07/15/1988SE |
| K874018 | NeuroprobeETN · Traditional | Inovx, Inc. | 06/01/1988SE |
| K880720 | Montgomery Nerve StimulatorETN · Traditional | Boston Medical Products, Inc. | 05/20/1988SE |
| K873964 | Nicolet Disposable Prass ProbeETN · Traditional | Nicolet Biomedical Instruments | 11/20/1987SE |
| K872791 | Porex Nerve LocatorETN · Traditional | Porex Medical | 10/20/1987SE |
| K870272 | Model 6110C OtophorETN · Traditional | Life-Tech Intl., Inc. | 08/05/1987SE |
| K843226 | Evoked Response Electrical StimulatorETN · Traditional | Nucleus, Ltd. | 05/21/1985SE |
| K833646 | Pulsatron Nerve Locator/StimulatorETN · Traditional | Edward Weck, Inc. | 02/10/1984SE |
| K831715 | NeurotracETN · Traditional | Hdc Corp. | 07/07/1983SE |
| K781569 | Nerve Locater/StimulatorETN · Traditional | Intermedics, Inc. | 12/07/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2100-2025 Class II | Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird -…Product packaging contains the wrong part number and kit contents. | Neurovision Medical Products Inc | 05/19/2025Open, Classified |
| Z-1467-2025 Class II | Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian…Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button… | Checkpoint Surgical Inc | 02/24/2025Open, Classified |
| Z-1466-2025 Class II | Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian…Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button… | Checkpoint Surgical Inc | 02/24/2025Open, Classified |
| Z-3131-2024 Class II | NEUROSIGN Disposable Stimulating Dissector, REF 5888-00Product has have presence of brown discoloration or substance on the hinge area of the device | Technomed Europe | 07/25/2024Open, Classified |
| Z-2719-2024 Class II | Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex…mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size. | Neurovision Medical Products Inc | 07/01/2024Open, Classified |
| Z-0696-2024 Class II | NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM…Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance… | Medtronic Xomed, Inc. | 11/07/2023Open, Classified |
| Z-1521-2022 Class I | NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306JThe firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG… | Medtronic Xomed, Inc. | 04/29/2022Open, Classified |
| Z-1520-2022 Class I | NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG… | Medtronic Xomed, Inc. | 04/29/2022Open, Classified |
| Z-1519-2022 Class I | NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF…The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG… | Medtronic Xomed, Inc. | 04/29/2022Open, Classified |
| Z-0743-2022 Class II | NIM TRIVANTAGE EMG Endotracheal TubeThere is potential for multiple issues due to a manufacturing nonconformity. | Medtronic Xomed, Inc. | 12/22/2021Open, Classified |
| Z-1971-2021 Class II | Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during…The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide… | Spes Medica | 04/08/2021Terminated |
| Z-1969-2021 Class II | Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference…The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide… | Spes Medica | 04/08/2021Terminated |
| Z-1967-2021 Class II | Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference…The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide… | Spes Medica | 04/08/2021Terminated |
| Z-0869-2021 Class II | Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage:…A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without being… | The Magstim Company Limited | 12/08/2020Terminated |
| Z-2908-2020 Class II | Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI:…The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften… | Neurovision Medical Products Inc | 07/21/2020Terminated |
| Z-2907-2020 Class II | Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI:…The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften… | Neurovision Medical Products Inc | 07/21/2020Terminated |
| Z-2906-2020 Class II | Cobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only, Sterile EO UDI:…The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften… | Neurovision Medical Products Inc | 07/21/2020Terminated |
| Z-2905-2020 Class II | Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI:…The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften… | Neurovision Medical Products Inc | 07/21/2020Terminated |
| Z-2904-2020 Class II | Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI:…The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften… | Neurovision Medical Products Inc | 07/21/2020Terminated |
| Z-2903-2020 Class II | Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI:…The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften… | Neurovision Medical Products Inc | 07/21/2020Terminated |
| Z-2902-2020 Class II | Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx…The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften… | Neurovision Medical Products Inc | 07/21/2020Terminated |
| Z-2901-2020 Class II | Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5…The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften… | Neurovision Medical Products Inc | 07/21/2020Terminated |
| Z-2900-2020 Class II | Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx…The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften… | Neurovision Medical Products Inc | 07/21/2020Terminated |
| Z-0024-2020 Class II | C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2…Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the… | Stryker Instruments Div. of Stryker… | 07/31/2019Terminated |
| Z-0023-2020 Class II | C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2…Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the… | Stryker Instruments Div. of Stryker… | 07/31/2019Terminated |
| Z-0901-2017 Class II | NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx…Wire in tubing can become exposed, posing potential harm to the intubated patient. | Medtronic Xomed, Inc. | 06/28/2016Terminated |
| Z-1960-2015 Class II | Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink…Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm | Spine Wave, Inc. | 05/04/2015Terminated |
| Z-1420-2013 Class I | REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic…In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in… | Medtronic Xomed, Inc. | 03/04/2013Terminated |
| Z-0798-2010 | 2-Channel Laryngeal Surface Electrode (Model LSE500DCS and LSE500DCL) For use as a…This recall has been initiated due to a conductive glue used to attach the lead wire to electrode, which has… | Neurovision Medical Products Inc | 01/11/2010Terminated |
| Z-0947-2009 | VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtronic Xomed, Inc. The Vari-Stim III…Device may fail to operate or operate intermittently during use and such operation could result in a lack of… | Medtronic Xomed, Inc. | 11/21/2008Terminated |