Product Code: ETN
FDA class 2
21 CFR 874.1820
Stimulator, Nerve
Ear, Nose, Throat
The nerve stimulator is a device used in ENT procedures to identify and test the integrity of peripheral nerves, such as the facial nerve, during surgery to reduce the risk of inadvertent nerve damage. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is ETN, regulated under 21 CFR 874.1820 in the Ear, Nose, Throat specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.
510(k)s
95
FEI Numbers
123
Registration Numbers
123
Unique Applicants
55
Years Active
47
Basic Information
- Product Code
- ETN
- Device Class
- FDA class 2
- Regulation Number
- 874.1820
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 95 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| 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) | Jun 13, 2025 | Substantially Equivalent | inomed Medizintechnik GmbH |
| K233001 | Bioscope Neuromonitor Device | Dec 13, 2024 | Substantially Equivalent | Biosys Biyomedikal Muhendislik San. Ve Tic. A.S. |
| K241917 | EARP Nerve Cuff Electrode | Jul 31, 2024 | Substantially Equivalent | Retropsoas Technologies, LLC |
| K232888 | Disposable Laryngeal Electrodes | Dec 21, 2023 | Substantially Equivalent | Suzhou Haishen Medical Device Associates Co., Ltd |
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube | Oct 26, 2023 | Substantially Equivalent | Medtronic Xomed, Inc. |
| K230853 | EARP Nerve Cuff Electrode | Oct 06, 2023 | Substantially Equivalent | Nvision Biomedical Technologies, Inc. |
| K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) | Aug 30, 2023 | Substantially Equivalent | Medtronic Xomed, Inc. |
| K223254 | C2 Xplore | Jan 27, 2023 | Substantially Equivalent | Inomed Medizintechnik GmbH |
| K212164 | Mapping Suction Probe | Nov 11, 2022 | Substantially Equivalent | inomed Medizintechnik GmbH |
| K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long | Mar 21, 2022 | Substantially Equivalent | Medtronic Xomed, Inc. |
| K212355 | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large | Aug 26, 2021 | Substantially Equivalent | Checkpoint Surgical |
| K200886 | StimSite | Nov 10, 2020 | Substantially Equivalent | Allotrope Medical Inc |
| K152769 | FREMAP ELECTRODE | May 06, 2016 | Substantially Equivalent | AD-TECH MEDICAL INSTRUMENT CORPORATION |
| K152505 | C2 NerveMonitor System | Feb 01, 2016 | Substantially Equivalent | INOMED MEDIZINTECHNIK GMBH |
| K150005 | Checkpoint, Checkpoint Head & Neck | Feb 19, 2015 | Substantially Equivalent | NDI Medical, LLC |
| K133348 | STIM PROBE | Nov 21, 2014 | Substantially Equivalent | SPES MEDICA S.R.L. |
| K140400 | ES2 NEUROMONITORING ACCESSORY INSTRUMENTS | Jul 01, 2014 | Substantially Equivalent | STRYKER CORPORATION |
| K122040 | INVOTEC LARYNGEAL ELECTRODE | Oct 31, 2013 | Substantially Equivalent | INVOTEC INTERNATIONAL, INC. |
| K121931 | NONDISPOSABLE STIMULATING INSTRUMENTS | Oct 19, 2012 | Substantially Equivalent | NEUROVISION MEDICAL PRODUCTS, INC. |
| K121257 | LARYNGEAL ELECTRODE | Aug 28, 2012 | Substantially Equivalent | TECHNOMED EUROPE |
| K112686 | NEXT GEN EMG ENDOTRACHEAL TUBE | Jun 27, 2012 | Substantially Equivalent | MEDTRONIC XOMED, INC. |
| K112717 | NUVASIVE NVJJB SYSTEM | Apr 13, 2012 | Substantially Equivalent | NUVASIVE, INC. |
| K112426 | XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES | Apr 02, 2012 | Substantially Equivalent | XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD. |
| K112718 | NUVASIVE NVM5 SYSTEM | Mar 16, 2012 | Substantially Equivalent | NUVASIVE, INC. |
| K112709 | STIMULATION/DISSECTION INSTRUMENTS | Feb 09, 2012 | Substantially Equivalent | NUVASIVE, INCORPORATED |
| K111671 | SEASPINE MONOPOLAR PROBE SYSYEM | Dec 28, 2011 | Substantially Equivalent | SEASPINE, INC. |
| K110989 | NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE | Nov 03, 2011 | Substantially Equivalent | NEUROVISION MEDICAL PRODUCTS, INC. |
| K111597 | DISPOSABLE STIMULATING ELECTRODE | Oct 13, 2011 | Substantially Equivalent | NUVASIVE, INC. |
| K112435 | RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT | Sep 22, 2011 | Substantially Equivalent | RHYTHMLINK INTERNATIONAL, LLC |
| K110696 | NEURO CHECK DEVICE WITH IO-FLEX WIRE | Jul 07, 2011 | Substantially Equivalent | BAXANO, INC. |
| K110712 | DRYTOUCH SUCTION STIMULATOR PROBE | Jun 28, 2011 | Substantially Equivalent | NEUROVISION MEDICAL PRODUCTS, INC. |
| K110422 | SURGICAL STIMULATORS | May 26, 2011 | Substantially Equivalent | TECHNOMED EUROPE |
| K110138 | PAIRED HYDROGEL ELECTRODE | Apr 08, 2011 | Substantially Equivalent | NEUROVISION MEDICAL PRODUCTS, INC. |
| K103128 | CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE, | Feb 23, 2011 | Substantially Equivalent | CADWELL LAB, INC. |
| K102862 | NEUROVISION SE (NERVEANA) | Dec 21, 2010 | Substantially Equivalent | NEUROVISION MEDICAL PRODUCTS, INC. |
| K100992 | NEURALMAS | Sep 24, 2010 | Substantially Equivalent | INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS") |
| K093373 | LARYNGEAL SURFACE ELECTRODE | Aug 24, 2010 | Substantially Equivalent | SPES MEDICA S.R.L. |
| K091874 | INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 | Nov 18, 2009 | Substantially Equivalent | INOMED MEDIZINTECHNIK GMBH |
| K092292 | CHECKPOINT | Oct 28, 2009 | Substantially Equivalent | NDI MEDICAL LLC |
| K092729 | BAXANO NEURO CHECK DEVICE | Oct 02, 2009 | Substantially Equivalent | BAXANO, INC. |
| K083242 | NEUROSIGN AVALANCHE MOTOR NERVE MONITOR | Jul 29, 2009 | Substantially Equivalent | THE MAGSTIM COMPANY LTD. |
| K090838 | STIMULUS/DISSECTION INSTRUMENTS | Jul 20, 2009 | Substantially Equivalent | AXON SYSTEMS, INC. |
| K081742 | BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 | Sep 17, 2008 | Substantially Equivalent | BAXANO, INC. |
| K072736 | RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT | Jan 22, 2008 | Substantially Equivalent | RHYTHMLINK INTERNATIONAL, LLC |
| K071349 | NEUROSIGN LARYNGEAL ELECTRODES | Dec 12, 2007 | Substantially Equivalent | THE MAGSTIM COMPANY LTD. |
| K063560 | HILGER DUAL-STIM NERVE STIMULATOR | Jan 05, 2007 | Substantially Equivalent | WR MEDICAL ELECTRONICS CO. |
| K063305 | STIMULATING BUR GUARD | Nov 29, 2006 | Substantially Equivalent | MEDTRONIC XOMED, INC. |
| K062549 | XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 | Oct 04, 2006 | Substantially Equivalent | EXCEL TECH. LTD. |
| K061365 | CHECKPOINT WITH ACCUSTIM TECHNOLOGY | Jul 12, 2006 | Substantially Equivalent | NDI MEDICAL, LLC |
| K053141 | NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 | Dec 14, 2005 | Substantially Equivalent | THE MAGSTIM COMPANY LTD. |
| K051718 | NUVASIVE NEUROVISION JJB SYSTEM | Sep 15, 2005 | Substantially Equivalent | NUVASIVE, INC. |
| K050162 | CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE | Mar 03, 2005 | Substantially Equivalent | MEDTRONIC XOMED, INC. |
| K040543 | NUVASIVE NEUROVISION JJB SYSTEM | Apr 01, 2004 | Substantially Equivalent | NUVASIVE, INC. |
| K032083 | NUVASIVE NEUROVISION JJB SYSTEM | Oct 24, 2003 | Substantially Equivalent | NUVASIVE, INC. |
| K031510 | NIM-SPINE | Jun 18, 2003 | Substantially Equivalent | MEDTRONIC XOMED |
| K031003 | STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES | Apr 11, 2003 | Substantially Equivalent | MEDTRONIC XOMED, INC. |
| K021595 | GYRUS ENT NERVE STIMULATOR | Oct 24, 2002 | Substantially Equivalent | GYRUS ENT L.L.C. |
| K020955 | NICOLET ELECTROCAUTERY DETECTOR | Apr 17, 2002 | Substantially Equivalent | NICOLET BIOMEDICAL, INC. |
| K014165 | STIMULUS - DISSECTION INSTRUMENTS | Jan 22, 2002 | Substantially Equivalent | MEDTRONIC XOMED, INC. |
| K010213 | MODIFICATION TO CAVERMAP SURGICAL AID | Apr 20, 2001 | Substantially Equivalent | UROMED CORP. |
| K003745 | LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET | Jan 16, 2001 | Substantially Equivalent | RLN SYSTEMS, INC. |
| K000507 | CAVERMAP SURGICAL AID | Apr 21, 2000 | Substantially Equivalent | UROMED CORP. |
| K992869 | XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE | Oct 07, 1999 | Substantially Equivalent | XOMED, INC. |
| K991583 | NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR | May 19, 1999 | Substantially Equivalent | THE MAGSTIM COMPANY LTD. |
| K982595 | NIM4 | Sep 04, 1998 | Substantially Equivalent | XOMED, INC. |
| K980148 | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR | Aug 05, 1998 | Substantially Equivalent | THE MAGSTIM COMPANY LTD. |
| K970971 | URO MED NERVE STIMULATOR | Oct 27, 1997 | Substantially Equivalent | UROMED CORP. |
| K971143 | NEURO PULSE II,III | Jun 06, 1997 | Substantially Equivalent | AARON MEDICAL INDUSTRIES |
| K964869 | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR | May 14, 1997 | Substantially Equivalent | THE MAGSTIM COMPANY LTD. |
| K954601 | NERVE LOCATOR/MONITOR SYSTEM MODIFICATION | Dec 22, 1995 | Substantially Equivalent | RLN SYSTEMS, INC. |
| K945799 | NEUROSIGN 100 IMPEDANCE METER | Jun 02, 1995 | Substantially Equivalent | THE MAGSTIM COMPANY LTD. |
| K951641 | NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR | May 09, 1995 | Substantially Equivalent | THE MAGSTIM COMPANY LTD. |
| K945242 | NERVE MONITOR ELECTRODES/STIMULATOR PROBES | Dec 27, 1994 | Substantially Equivalent | MICROMED DEVELOPMENT CORP. |
| K934733 | STIMULATING SURGICAL INSTRUMENTS | Jul 20, 1994 | Substantially Equivalent | SMITH & NEPHEW RICHARDS, INC. |
| K934426 | NERVE INTEGRITY MONITOR-2 (NIM-2 XL) | May 13, 1994 | Substantially Equivalent | XOMED-TREACE, INC. |
| K933491 | R AND D BATTERIES, INC. PART NOS. 5038 & 5347 | Nov 19, 1993 | Substantially Equivalent | R & D BATTERIES, INC. |
| K925640 | XOMED-TREACE EMG ENDOTRACHEAL TUBEEN | Aug 17, 1993 | Substantially Equivalent | XOMED-TREACE, INC. |
| K925008 | RLN NERVE LOCATOR/MONITOR; MODEL A | Nov 24, 1992 | Substantially Equivalent | RLN SYSTEMS, INC. |
| K923056 | NEUROSIGN MODEL 100 | Nov 24, 1992 | Substantially Equivalent | THE MAGSTIM COMPANY LTD. |
| K912508 | NERVE LOCATOR/MONITOR SYSTEM, MODIFICATION | Sep 30, 1992 | Substantially Equivalent | RLN SYSTEMS, INC. |
| K905035 | AXOSTIM NERVE STIMULATOR, MODIFICATION | Apr 19, 1991 | Substantially Equivalent | SINGER MEDICAL PRODUCTS, INC. |
| K905045 | NERVE LOCATOR/STIMULATOR | Mar 15, 1991 | Substantially Equivalent | AARON MEDICAL INDUSTRIES |
| K895838 | BRACKMANN EMG MONITORING SYSTEM | Mar 27, 1990 | Substantially Equivalent | WR MEDICAL ELECTRONICS CO. |
| K894930 | DENTEC 4000 | Mar 27, 1990 | Substantially Equivalent | DENTEC, INC. |
| K895676 | HEMOSTAT/STIMULATOR PROBE | Dec 08, 1989 | Substantially Equivalent | RLN SYSTEMS, INC. |
| K881757 | RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS | Jul 15, 1988 | Substantially Equivalent | DOWNS SURGICAL LTD. |
| K874018 | NEUROPROBE | Jun 01, 1988 | Substantially Equivalent | INOVX, INC. |
| K880720 | MONTGOMERY NERVE STIMULATOR | May 20, 1988 | Substantially Equivalent | BOSTON MEDICAL PRODUCTS, INC. |
| K873964 | NICOLET DISPOSABLE PRASS PROBE | Nov 20, 1987 | Substantially Equivalent | NICOLET BIOMEDICAL INSTRUMENTS |
| K872791 | POREX NERVE LOCATOR | Oct 20, 1987 | Substantially Equivalent | POREX MEDICAL |
| K870272 | MODEL 6110C OTOPHOR | Aug 05, 1987 | Substantially Equivalent | LIFE-TECH INTL., INC. |
| K843226 | EVOKED RESPONSE ELECTRICAL STIMULATOR | May 21, 1985 | Substantially Equivalent | NUCLEUS, LTD. |
| K833646 | PULSATRON NERVE LOCATOR/STIMULATOR | Feb 10, 1984 | Substantially Equivalent | EDWARD WECK, INC. |
| K831715 | NEUROTRAC | Jul 07, 1983 | Substantially Equivalent | HDC CORP. |
| K781569 | NERVE LOCATER/STIMULATOR | Dec 07, 1978 | Substantially Equivalent | INTERMEDICS, INC. |
FEI Numbers
This FDA classification entry is associated with 123 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 123 registration numbers. Click on an entry to view related FDA registrations.