FDA 510(k) Applications for Medical Device Product Code "ETN"
(Stimulator, Nerve)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K971143 | AARON MEDICAL INDUSTRIES | NEURO PULSE II,III | 06/06/1997 |
| K152769 | AD-TECH MEDICAL INSTRUMENT CORPORATION | FREMAP ELECTRODE | 05/06/2016 |
| K200886 | Allotrope Medical Inc | StimSite | 11/10/2020 |
| K090838 | AXON SYSTEMS, INC. | STIMULUS/DISSECTION INSTRUMENTS | 07/20/2009 |
| K081742 | BAXANO, INC. | BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 | 09/17/2008 |
| K092729 | BAXANO, INC. | BAXANO NEURO CHECK DEVICE | 10/02/2009 |
| K110696 | BAXANO, INC. | NEURO CHECK DEVICE WITH IO-FLEX WIRE | 07/07/2011 |
| K233001 | Biosys Biyomedikal Muhendislik San. Ve Tic. A.S. | Bioscope Neuromonitor Device | 12/13/2024 |
| K103128 | CADWELL LAB, INC. | CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE, | 02/23/2011 |
| K212355 | Checkpoint Surgical | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large | 08/26/2021 |
| K062549 | EXCEL TECH. LTD. | XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 | 10/04/2006 |
| K021595 | GYRUS ENT L.L.C. | GYRUS ENT NERVE STIMULATOR | 10/24/2002 |
| K100992 | INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS") | NEURALMAS | 09/24/2010 |
| K242852 | inomed Medizintechnik GmbH | ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) | 06/13/2025 |
| K152505 | INOMED MEDIZINTECHNIK GMBH | C2 NerveMonitor System | 02/01/2016 |
| K223254 | Inomed Medizintechnik GmbH | C2 Xplore | 01/27/2023 |
| K091874 | INOMED MEDIZINTECHNIK GMBH | INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 | 11/18/2009 |
| K212164 | inomed Medizintechnik GmbH | Mapping Suction Probe | 11/11/2022 |
| K122040 | INVOTEC INTERNATIONAL, INC. | INVOTEC LARYNGEAL ELECTRODE | 10/31/2013 |
| K031510 | MEDTRONIC XOMED | NIM-SPINE | 06/18/2003 |
| K050162 | MEDTRONIC XOMED, INC. | CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE | 03/03/2005 |
| K112686 | MEDTRONIC XOMED, INC. | NEXT GEN EMG ENDOTRACHEAL TUBE | 06/27/2012 |
| K230320 | Medtronic Xomed, Inc. | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube | 10/26/2023 |
| K213246 | Medtronic Xomed, Inc. | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long | 03/21/2022 |
| K231580 | Medtronic Xomed, Inc. | NIMÖ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) | 08/30/2023 |
| K063305 | MEDTRONIC XOMED, INC. | STIMULATING BUR GUARD | 11/29/2006 |
| K014165 | MEDTRONIC XOMED, INC. | STIMULUS - DISSECTION INSTRUMENTS | 01/22/2002 |
| K031003 | MEDTRONIC XOMED, INC. | STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES | 04/11/2003 |
| K092292 | NDI MEDICAL LLC | CHECKPOINT | 10/28/2009 |
| K061365 | NDI MEDICAL, LLC | CHECKPOINT WITH ACCUSTIM TECHNOLOGY | 07/12/2006 |
| K150005 | NDI Medical, LLC | Checkpoint, Checkpoint Head & Neck | 02/19/2015 |
| K110712 | NEUROVISION MEDICAL PRODUCTS, INC. | DRYTOUCH SUCTION STIMULATOR PROBE | 06/28/2011 |
| K110989 | NEUROVISION MEDICAL PRODUCTS, INC. | NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE | 11/03/2011 |
| K102862 | NEUROVISION MEDICAL PRODUCTS, INC. | NEUROVISION SE (NERVEANA) | 12/21/2010 |
| K121931 | NEUROVISION MEDICAL PRODUCTS, INC. | NONDISPOSABLE STIMULATING INSTRUMENTS | 10/19/2012 |
| K110138 | NEUROVISION MEDICAL PRODUCTS, INC. | PAIRED HYDROGEL ELECTRODE | 04/08/2011 |
| K020955 | NICOLET BIOMEDICAL, INC. | NICOLET ELECTROCAUTERY DETECTOR | 04/17/2002 |
| K111597 | NUVASIVE, INC. | DISPOSABLE STIMULATING ELECTRODE | 10/13/2011 |
| K032083 | NUVASIVE, INC. | NUVASIVE NEUROVISION JJB SYSTEM | 10/24/2003 |
| K040543 | NUVASIVE, INC. | NUVASIVE NEUROVISION JJB SYSTEM | 04/01/2004 |
| K051718 | NUVASIVE, INC. | NUVASIVE NEUROVISION JJB SYSTEM | 09/15/2005 |
| K112717 | NUVASIVE, INC. | NUVASIVE NVJJB SYSTEM | 04/13/2012 |
| K112718 | NUVASIVE, INC. | NUVASIVE NVM5 SYSTEM | 03/16/2012 |
| K112709 | NUVASIVE, INCORPORATED | STIMULATION/DISSECTION INSTRUMENTS | 02/09/2012 |
| K230853 | Nvision Biomedical Technologies, Inc. | EARP Nerve Cuff Electrode | 10/06/2023 |
| K241917 | Retropsoas Technologies, LLC | EARP Nerve Cuff Electrode | 07/31/2024 |
| K072736 | RHYTHMLINK INTERNATIONAL, LLC | RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT | 01/22/2008 |
| K112435 | RHYTHMLINK INTERNATIONAL, LLC | RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT | 09/22/2011 |
| K003745 | RLN SYSTEMS, INC. | LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET | 01/16/2001 |
| K111671 | SEASPINE, INC. | SEASPINE MONOPOLAR PROBE SYSYEM | 12/28/2011 |
| K093373 | SPES MEDICA S.R.L. | LARYNGEAL SURFACE ELECTRODE | 08/24/2010 |
| K133348 | SPES MEDICA S.R.L. | STIM PROBE | 11/21/2014 |
| K140400 | STRYKER CORPORATION | ES2 NEUROMONITORING ACCESSORY INSTRUMENTS | 07/01/2014 |
| K232888 | Suzhou Haishen Medical Device Associates Co., Ltd | Disposable Laryngeal Electrodes | 12/21/2023 |
| K121257 | TECHNOMED EUROPE | LARYNGEAL ELECTRODE | 08/28/2012 |
| K110422 | TECHNOMED EUROPE | SURGICAL STIMULATORS | 05/26/2011 |
| K991583 | THE MAGSTIM COMPANY LTD. | NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR | 05/19/1999 |
| K964869 | THE MAGSTIM COMPANY LTD. | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR | 05/14/1997 |
| K980148 | THE MAGSTIM COMPANY LTD. | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR | 08/05/1998 |
| K083242 | THE MAGSTIM COMPANY LTD. | NEUROSIGN AVALANCHE MOTOR NERVE MONITOR | 07/29/2009 |
| K071349 | THE MAGSTIM COMPANY LTD. | NEUROSIGN LARYNGEAL ELECTRODES | 12/12/2007 |
| K053141 | THE MAGSTIM COMPANY LTD. | NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 | 12/14/2005 |
| K000507 | UROMED CORP. | CAVERMAP SURGICAL AID | 04/21/2000 |
| K010213 | UROMED CORP. | MODIFICATION TO CAVERMAP SURGICAL AID | 04/20/2001 |
| K970971 | UROMED CORP. | URO MED NERVE STIMULATOR | 10/27/1997 |
| K063560 | WR MEDICAL ELECTRONICS CO. | HILGER DUAL-STIM NERVE STIMULATOR | 01/05/2007 |
| K112426 | XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD. | XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES | 04/02/2012 |
| K982595 | XOMED, INC. | NIM4 | 09/04/1998 |
| K992869 | XOMED, INC. | XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE | 10/07/1999 |
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