ETN · Stimulator, Nerve
Ear, Nose, Throat · 21 CFR 874.1820 · Class 2
Overview
| Product Code | ETN |
|---|---|
| Device Name | Stimulator, Nerve |
| Regulation | 21 CFR 874.1820 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
Identification
A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.
Classification Rationale
Class II.
Cleared Devices (97)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253536 | Evala Nerve Stimulator (EPNR002) | Epineuron Technologies, Inc. | Feb 27, 2026 | SESE |
| K251672 | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotracheal Tube (NIMEID070); NIM Essence EMG Endotracheal Tube (NIMEID075); NIM Essence EMG Endotracheal Tube (NIMEID080) | Medtronic Xomed, Inc. | Feb 10, 2026 | SESE |
| 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 I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) | Inomed Medizintechnik GmbH | Jun 13, 2025 | SESE |
| K233001 | Bioscope Neuromonitor Device | Biosys Biyomedikal Muhendislik San. VE Tic. A.S. | Dec 13, 2024 | SESE |
| K241917 | EARP Nerve Cuff Electrode | Retropsoas Technologies, LLC | Jul 31, 2024 | SESE |
| K232888 | Disposable Laryngeal Electrodes | Suzhou Haishen Medical Device Associates Co., Ltd. | Dec 21, 2023 | SESE |
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube | Medtronic Xomed, Inc. | Oct 26, 2023 | SESE |
| K230853 | EARP Nerve Cuff Electrode | Nvision Biomedical Technologies, Inc. | Oct 6, 2023 | SESE |
| K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) | Medtronic Xomed, Inc. | Aug 30, 2023 | SESE |
| K223254 | C2 Xplore | Inomed Medizintechnik GmbH | Jan 27, 2023 | SESE |
| K212164 | Mapping Suction Probe | Inomed Medizintechnik GmbH | Nov 11, 2022 | SESE |
| K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long | Medtronic Xomed, Inc. | Mar 21, 2022 | SESE |
| K212355 | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large | Checkpoint Surgical | Aug 26, 2021 | SESE |
| K200886 | StimSite | Allotrope Medical, Inc. | Nov 10, 2020 | SESE |
| K152769 | FREMAP ELECTRODE | Ad-Tech Medical Instrument Corporation | May 6, 2016 | SESE |
| K152505 | C2 NerveMonitor System | Inomed Medizintechnik GmbH | Feb 1, 2016 | SESE |
| K150005 | Checkpoint, Checkpoint Head & Neck | Ndi Medical, LLC | Feb 19, 2015 | SESE |
| K133348 | STIM PROBE | Spes Medica Srl | Nov 21, 2014 | SESE |
| K140400 | ES2 NEUROMONITORING ACCESSORY INSTRUMENTS | Stryker Corporation | Jul 1, 2014 | SESE |
| K122040 | INVOTEC LARYNGEAL ELECTRODE | Invotec International, Inc. | Oct 31, 2013 | SESE |
| K121931 | NONDISPOSABLE STIMULATING INSTRUMENTS | Neurovision Medical Products, Inc. | Oct 19, 2012 | SESE |
| K121257 | LARYNGEAL ELECTRODE | Technomed Europe | Aug 28, 2012 | SESE |
| K112686 | NEXT GEN EMG ENDOTRACHEAL TUBE | Medtronic Xomed, Inc. | Jun 27, 2012 | SESE |
| K112717 | NUVASIVE NVJJB SYSTEM | Nuvasive, Inc. | Apr 13, 2012 | SESE |
| K112426 | XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES | Xian Friendship Medical Electronics Co., Ltd. | Apr 2, 2012 | SESE |
| K112718 | NUVASIVE NVM5 SYSTEM | Nuvasive, Inc. | Mar 16, 2012 | SESE |
| K112709 | STIMULATION/DISSECTION INSTRUMENTS | Nu Vasive, Incorporated | Feb 9, 2012 | SESE |
| K111671 | SEASPINE MONOPOLAR PROBE SYSYEM | Seaspine, Inc. | Dec 28, 2011 | SESE |
| K110989 | NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE | Neurovision Medical Products, Inc. | Nov 3, 2011 | SESE |
| K111597 | DISPOSABLE STIMULATING ELECTRODE | Nuvasive, Inc. | Oct 13, 2011 | SESE |
| K112435 | RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT | Rhythmlink International, LLC | Sep 22, 2011 | SESE |
| K110696 | NEURO CHECK DEVICE WITH IO-FLEX WIRE | Baxano, Inc. | Jul 7, 2011 | SESE |
| K110712 | DRYTOUCH SUCTION STIMULATOR PROBE | Neurovision Medical Products, Inc. | Jun 28, 2011 | SESE |
| K110422 | SURGICAL STIMULATORS | Technomed Europe | May 26, 2011 | SESE |
| K110138 | PAIRED HYDROGEL ELECTRODE | Neurovision Medical Products, Inc. | Apr 8, 2011 | SESE |
| K103128 | CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE, | Cadwell Lab, Inc. | Feb 23, 2011 | SESE |
| K102862 | NEUROVISION SE (NERVEANA) | Neurovision Medical Products, Inc. | Dec 21, 2010 | SESE |
| K100992 | NEURALMAS | Innovative Surgical Solutions, LLC ("Iss") | Sep 24, 2010 | SESE |
| K093373 | LARYNGEAL SURFACE ELECTRODE | Spes Medica Srl | Aug 24, 2010 | SESE |
| K091874 | INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 | Inomed Medizintechnik GmbH | Nov 18, 2009 | SESE |
| K092292 | CHECKPOINT | Ndi Medical, LLC | Oct 28, 2009 | SESE |
| K092729 | BAXANO NEURO CHECK DEVICE | Baxano, Inc. | Oct 2, 2009 | SESE |
| K083242 | NEUROSIGN AVALANCHE MOTOR NERVE MONITOR | The Magstim Company , Ltd. | Jul 29, 2009 | SESE |
| K090838 | STIMULUS/DISSECTION INSTRUMENTS | Axon Systems, Inc. | Jul 20, 2009 | SESE |
| K081742 | BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 | Baxano, Inc. | Sep 17, 2008 | SESE |
| K072736 | RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT | Rhythmlink International, LLC | Jan 22, 2008 | SESE |
| K071349 | NEUROSIGN LARYNGEAL ELECTRODES | The Magstim Company , Ltd. | Dec 12, 2007 | SESE |
| K063560 | HILGER DUAL-STIM NERVE STIMULATOR | Wr Medical Electronics Co. | Jan 5, 2007 | SESE |
| K063305 | STIMULATING BUR GUARD | Medtronic Xomed, Inc. | Nov 29, 2006 | SESE |
| K062549 | XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 | Excel Tech. , Ltd. | Oct 4, 2006 | SESE |
| K061365 | CHECKPOINT WITH ACCUSTIM TECHNOLOGY | Ndi Medical, LLC | Jul 12, 2006 | SESE |
| K053141 | NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 | The Magstim Company , Ltd. | Dec 14, 2005 | SESE |
| K051718 | NUVASIVE NEUROVISION JJB SYSTEM | Nuvasive, Inc. | Sep 15, 2005 | SESE |
| K050162 | CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE | Medtronic Xomed, Inc. | Mar 3, 2005 | SESE |
| K040543 | NUVASIVE NEUROVISION JJB SYSTEM | Nuvasive, Inc. | Apr 1, 2004 | SESE |
| K032083 | NUVASIVE NEUROVISION JJB SYSTEM | Nuvasive, Inc. | Oct 24, 2003 | SESE |
| K031510 | NIM-SPINE | Medtronic Xomed | Jun 18, 2003 | SESE |
| K031003 | STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES | Medtronic Xomed, Inc. | Apr 11, 2003 | SESE |
| K021595 | GYRUS ENT NERVE STIMULATOR | Gyrus Ent LLC | Oct 24, 2002 | SESE |
| K020955 | NICOLET ELECTROCAUTERY DETECTOR | Nicolet Biomedical, Inc. | Apr 17, 2002 | SESE |
| K014165 | STIMULUS - DISSECTION INSTRUMENTS | Medtronic Xomed, Inc. | Jan 22, 2002 | SESE |
| K010213 | MODIFICATION TO CAVERMAP SURGICAL AID | Uromed Corp. | Apr 20, 2001 | SESE |
| K003745 | LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET | Rln Systems, Inc. | Jan 16, 2001 | SESE |
| K000507 | CAVERMAP SURGICAL AID | Uromed Corp. | Apr 21, 2000 | SESE |
| K992869 | XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE | Xomed, Inc. | Oct 7, 1999 | SESE |
| K991583 | NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR | The Magstim Company , Ltd. | May 19, 1999 | SESE |
| K982595 | NIM4 | Xomed, Inc. | Sep 4, 1998 | SESE |
| K980148 | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR | The Magstim Company , Ltd. | Aug 5, 1998 | SESE |
| K970971 | URO MED NERVE STIMULATOR | Uromed Corp. | Oct 27, 1997 | SESE |
| K971143 | NEURO PULSE II,III | Aaron Medical Industries | Jun 6, 1997 | SESE |
| K964869 | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR | The Magstim Company , Ltd. | May 14, 1997 | SESE |
| K954601 | NERVE LOCATOR/MONITOR SYSTEM MODIFICATION | Rln Systems, Inc. | Dec 22, 1995 | SESE |
| K945799 | NEUROSIGN 100 IMPEDANCE METER | The Magstim Company , Ltd. | Jun 2, 1995 | SESE |
| K951641 | NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR | The Magstim Company , Ltd. | May 9, 1995 | SESE |
| K945242 | NERVE MONITOR ELECTRODES/STIMULATOR PROBES | Micromed Development Corp. | Dec 27, 1994 | SESE |
| K934733 | STIMULATING SURGICAL INSTRUMENTS | Smith & Nephew Richards, Inc. | Jul 20, 1994 | SESE |
| K934426 | NERVE INTEGRITY MONITOR-2 (NIM-2 XL) | Xomed-Treace, Inc. | May 13, 1994 | SESE |
| K933491 | R AND D BATTERIES, INC. PART NOS. 5038 & 5347 | R & D Batteries, Inc. | Nov 19, 1993 | SESE |
| K925640 | XOMED-TREACE EMG ENDOTRACHEAL TUBEEN | Xomed-Treace, Inc. | Aug 17, 1993 | SESE |
| K925008 | RLN NERVE LOCATOR/MONITOR; MODEL A | Rln Systems, Inc. | Nov 24, 1992 | SESE |
| K923056 | NEUROSIGN MODEL 100 | The Magstim Company , Ltd. | Nov 24, 1992 | SESE |
| K912508 | NERVE LOCATOR/MONITOR SYSTEM, MODIFICATION | Rln Systems, Inc. | Sep 30, 1992 | SESE |
| K905035 | AXOSTIM NERVE STIMULATOR, MODIFICATION | Singer Medical Products, Inc. | Apr 19, 1991 | SESE |
| K905045 | NERVE LOCATOR/STIMULATOR | Aaron Medical Industries | Mar 15, 1991 | SESE |
| K895838 | BRACKMANN EMG MONITORING SYSTEM | Wr Medical Electronics Co. | Mar 27, 1990 | SESE |
| K894930 | DENTEC 4000 | Dentec, Inc. | Mar 27, 1990 | SESE |
| K895676 | HEMOSTAT/STIMULATOR PROBE | Rln Systems, Inc. | Dec 8, 1989 | SESE |
| K881757 | RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS | Downs Surgical , Ltd. | Jul 15, 1988 | SESE |
| K874018 | NEUROPROBE | Inovx, Inc. | Jun 1, 1988 | SESE |
| K880720 | MONTGOMERY NERVE STIMULATOR | Boston Medical Products, Inc. | May 20, 1988 | SESE |
| K873964 | NICOLET DISPOSABLE PRASS PROBE | Nicolet Biomedical Instruments | Nov 20, 1987 | SESE |
| K872791 | POREX NERVE LOCATOR | Porex Medical | Oct 20, 1987 | SESE |
| K870272 | MODEL 6110C OTOPHOR | Life-Tech Intl., Inc. | Aug 5, 1987 | SESE |
| K843226 | EVOKED RESPONSE ELECTRICAL STIMULATOR | Nucleus, Ltd. | May 21, 1985 | SESE |
| K833646 | PULSATRON NERVE LOCATOR/STIMULATOR | Edward Weck, Inc. | Feb 10, 1984 | SESE |
| K831715 | NEUROTRAC | Hdc Corp. | Jul 7, 1983 | SESE |
| K781569 | NERVE LOCATER/STIMULATOR | Intermedics, Inc. | Dec 7, 1978 | SESE |
Top Applicants
- The Magstim Company , Ltd. — 9 clearances
- Medtronic Xomed, Inc. — 9 clearances
- Nuvasive, Inc. — 6 clearances
- Rln Systems, Inc. — 5 clearances
- Neurovision Medical Products, Inc. — 5 clearances
