FDA Product Code
FDA Product Code ETN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.1820
510(k) Clearances — 97 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253536 | Evala Nerve Stimulator (EPNR002) | Epineuron Technologies, Inc. | 2026-02-27 | Traditional | PDF ↗ |
| 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. | 2026-02-10 | Traditional | PDF ↗ |
| 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 | 2025-06-13 | Traditional | PDF ↗ |
| K233001 | Bioscope Neuromonitor Device | Biosys Biyomedikal Muhendislik San. VE Tic. A.S. | 2024-12-13 | Traditional | PDF ↗ |
| K241917 | EARP Nerve Cuff Electrode | Retropsoas Technologies, LLC | 2024-07-31 | Special | PDF ↗ |
| K232888 | Disposable Laryngeal Electrodes | Suzhou Haishen Medical Device Associates Co., Ltd. | 2023-12-21 | Traditional | PDF ↗ |
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube | Medtronic Xomed, Inc. | 2023-10-26 | Special | PDF ↗ |
| K230853 | EARP Nerve Cuff Electrode | Nvision Biomedical Technologies, Inc. | 2023-10-06 | Traditional | PDF ↗ |
| K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) | Medtronic Xomed, Inc. | 2023-08-30 | Traditional | PDF ↗ |
| K223254 | C2 Xplore | Inomed Medizintechnik GmbH | 2023-01-27 | Traditional | PDF ↗ |
| K212164 | Mapping Suction Probe | Inomed Medizintechnik GmbH | 2022-11-11 | Traditional | PDF ↗ |
| 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. | 2022-03-21 | Traditional | PDF ↗ |
| K212355 | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large | Checkpoint Surgical | 2021-08-26 | Special | PDF ↗ |
| K200886 | StimSite | Allotrope Medical, Inc. | 2020-11-10 | Traditional | PDF ↗ |
| K152769 | FREMAP ELECTRODE | Ad-Tech Medical Instrument Corporation | 2016-05-06 | Traditional | PDF ↗ |
| K152505 | C2 NerveMonitor System | Inomed Medizintechnik GmbH | 2016-02-01 | Traditional | PDF ↗ |
| K150005 | Checkpoint, Checkpoint Head & Neck | Ndi Medical, LLC | 2015-02-19 | Special | PDF ↗ |
| K133348 | STIM PROBE | Spes Medica Srl | 2014-11-21 | Traditional | PDF ↗ |
| K140400 | ES2 NEUROMONITORING ACCESSORY INSTRUMENTS | Stryker Corporation | 2014-07-01 | Traditional | PDF ↗ |
| K122040 | INVOTEC LARYNGEAL ELECTRODE | Invotec International, Inc. | 2013-10-31 | Traditional | PDF ↗ |
| K121931 | NONDISPOSABLE STIMULATING INSTRUMENTS | Neurovision Medical Products, Inc. | 2012-10-19 | Traditional | PDF ↗ |
| K121257 | LARYNGEAL ELECTRODE | Technomed Europe | 2012-08-28 | Traditional | PDF ↗ |
| K112686 | NEXT GEN EMG ENDOTRACHEAL TUBE | Medtronic Xomed, Inc. | 2012-06-27 | Traditional | PDF ↗ |
| K112717 | NUVASIVE NVJJB SYSTEM | Nuvasive, Inc. | 2012-04-13 | Traditional | PDF ↗ |
| K112426 | XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES | Xian Friendship Medical Electronics Co., Ltd. | 2012-04-02 | Traditional | PDF ↗ |
| K112718 | NUVASIVE NVM5 SYSTEM | Nuvasive, Inc. | 2012-03-16 | Traditional | PDF ↗ |
| K112709 | STIMULATION/DISSECTION INSTRUMENTS | Nu Vasive, Incorporated | 2012-02-09 | Traditional | PDF ↗ |
| K111671 | SEASPINE MONOPOLAR PROBE SYSYEM | Seaspine, Inc. | 2011-12-28 | Traditional | PDF ↗ |
| K110989 | NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE | Neurovision Medical Products, Inc. | 2011-11-03 | Traditional | PDF ↗ |
| K111597 | DISPOSABLE STIMULATING ELECTRODE | Nuvasive, Inc. | 2011-10-13 | Traditional | PDF ↗ |
| K112435 | RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT | Rhythmlink International, LLC | 2011-09-22 | Special | PDF ↗ |
| K110696 | NEURO CHECK DEVICE WITH IO-FLEX WIRE | Baxano, Inc. | 2011-07-07 | Traditional | PDF ↗ |
| K110712 | DRYTOUCH SUCTION STIMULATOR PROBE | Neurovision Medical Products, Inc. | 2011-06-28 | Traditional | PDF ↗ |
| K110422 | SURGICAL STIMULATORS | Technomed Europe | 2011-05-26 | Traditional | PDF ↗ |
| K110138 | PAIRED HYDROGEL ELECTRODE | Neurovision Medical Products, Inc. | 2011-04-08 | Special | PDF ↗ |
| K103128 | CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE, | Cadwell Lab, Inc. | 2011-02-23 | Traditional | PDF ↗ |
| K102862 | NEUROVISION SE (NERVEANA) | Neurovision Medical Products, Inc. | 2010-12-21 | Traditional | PDF ↗ |
| K100992 | NEURALMAS | Innovative Surgical Solutions, LLC ("Iss") | 2010-09-24 | Traditional | PDF ↗ |
| K093373 | LARYNGEAL SURFACE ELECTRODE | Spes Medica Srl | 2010-08-24 | Traditional | PDF ↗ |
| K091874 | INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 | Inomed Medizintechnik GmbH | 2009-11-18 | Traditional | PDF ↗ |
| K092292 | CHECKPOINT | Ndi Medical, LLC | 2009-10-28 | Traditional | PDF ↗ |
| K092729 | BAXANO NEURO CHECK DEVICE | Baxano, Inc. | 2009-10-02 | Special | PDF ↗ |
| K083242 | NEUROSIGN AVALANCHE MOTOR NERVE MONITOR | The Magstim Company , Ltd. | 2009-07-29 | Traditional | PDF ↗ |
| K090838 | STIMULUS/DISSECTION INSTRUMENTS | Axon Systems, Inc. | 2009-07-20 | Traditional | PDF ↗ |
| K081742 | BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 | Baxano, Inc. | 2008-09-17 | Traditional | PDF ↗ |
| K072736 | RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT | Rhythmlink International, LLC | 2008-01-22 | Traditional | PDF ↗ |
| K071349 | NEUROSIGN LARYNGEAL ELECTRODES | The Magstim Company , Ltd. | 2007-12-12 | Traditional | PDF ↗ |
| K063560 | HILGER DUAL-STIM NERVE STIMULATOR | Wr Medical Electronics Co. | 2007-01-05 | Abbreviated | PDF ↗ |
| K063305 | STIMULATING BUR GUARD | Medtronic Xomed, Inc. | 2006-11-29 | Traditional | PDF ↗ |
| K062549 | XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 | Excel Tech. , Ltd. | 2006-10-04 | Traditional | PDF ↗ |
| K061365 | CHECKPOINT WITH ACCUSTIM TECHNOLOGY | Ndi Medical, LLC | 2006-07-12 | Traditional | PDF ↗ |
| K053141 | NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 | The Magstim Company , Ltd. | 2005-12-14 | Special | PDF ↗ |
| K051718 | NUVASIVE NEUROVISION JJB SYSTEM | Nuvasive, Inc. | 2005-09-15 | Traditional | PDF ↗ |
| K050162 | CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE | Medtronic Xomed, Inc. | 2005-03-03 | Traditional | PDF ↗ |
| K040543 | NUVASIVE NEUROVISION JJB SYSTEM | Nuvasive, Inc. | 2004-04-01 | Special | PDF ↗ |
| K032083 | NUVASIVE NEUROVISION JJB SYSTEM | Nuvasive, Inc. | 2003-10-24 | Traditional | PDF ↗ |
| K031510 | NIM-SPINE | Medtronic Xomed | 2003-06-18 | Traditional | PDF ↗ |
| K031003 | STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES | Medtronic Xomed, Inc. | 2003-04-11 | Special | PDF ↗ |
| K021595 | GYRUS ENT NERVE STIMULATOR | Gyrus Ent LLC | 2002-10-24 | Traditional | PDF ↗ |
| K020955 | NICOLET ELECTROCAUTERY DETECTOR | Nicolet Biomedical, Inc. | 2002-04-17 | Abbreviated | PDF ↗ |
| K014165 | STIMULUS - DISSECTION INSTRUMENTS | Medtronic Xomed, Inc. | 2002-01-22 | Traditional | PDF ↗ |
| K010213 | MODIFICATION TO CAVERMAP SURGICAL AID | Uromed Corp. | 2001-04-20 | Traditional | PDF ↗ |
| K003745 | LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET | Rln Systems, Inc. | 2001-01-16 | Traditional | PDF ↗ |
| K000507 | CAVERMAP SURGICAL AID | Uromed Corp. | 2000-04-21 | Traditional | PDF ↗ |
| K992869 | XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE | Xomed, Inc. | 1999-10-07 | Traditional | PDF ↗ |
| K991583 | NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR | The Magstim Company , Ltd. | 1999-05-19 | Special | PDF ↗ |
| K982595 | NIM4 | Xomed, Inc. | 1998-09-04 | Traditional | PDF ↗ |
| K980148 | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR | The Magstim Company , Ltd. | 1998-08-05 | Traditional | PDF ↗ |
| K970971 | URO MED NERVE STIMULATOR | Uromed Corp. | 1997-10-27 | Traditional | PDF ↗ |
| K971143 | NEURO PULSE II,III | Aaron Medical Industries | 1997-06-06 | Traditional | PDF ↗ |
| K964869 | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR | The Magstim Company , Ltd. | 1997-05-14 | Traditional | PDF ↗ |
| K954601 | NERVE LOCATOR/MONITOR SYSTEM MODIFICATION | Rln Systems, Inc. | 1995-12-22 | Traditional | PDF ↗ |
| K945799 | NEUROSIGN 100 IMPEDANCE METER | The Magstim Company , Ltd. | 1995-06-02 | Traditional | PDF ↗ |
| K951641 | NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR | The Magstim Company , Ltd. | 1995-05-09 | Traditional | PDF ↗ |
| K945242 | NERVE MONITOR ELECTRODES/STIMULATOR PROBES | Micromed Development Corp. | 1994-12-27 | Traditional | PDF ↗ |
| K934733 | STIMULATING SURGICAL INSTRUMENTS | Smith & Nephew Richards, Inc. | 1994-07-20 | Traditional | PDF ↗ |
| K934426 | NERVE INTEGRITY MONITOR-2 (NIM-2 XL) | Xomed-Treace, Inc. | 1994-05-13 | Traditional | PDF ↗ |
| K933491 | R AND D BATTERIES, INC. PART NOS. 5038 & 5347 | R & D Batteries, Inc. | 1993-11-19 | Traditional | PDF ↗ |
| K925640 | XOMED-TREACE EMG ENDOTRACHEAL TUBEEN | Xomed-Treace, Inc. | 1993-08-17 | Traditional | PDF ↗ |
| K925008 | RLN NERVE LOCATOR/MONITOR; MODEL A | Rln Systems, Inc. | 1992-11-24 | Traditional | PDF ↗ |
| K923056 | NEUROSIGN MODEL 100 | The Magstim Company , Ltd. | 1992-11-24 | Traditional | PDF ↗ |
| K912508 | NERVE LOCATOR/MONITOR SYSTEM, MODIFICATION | Rln Systems, Inc. | 1992-09-30 | Traditional | PDF ↗ |
| K905035 | AXOSTIM NERVE STIMULATOR, MODIFICATION | Singer Medical Products, Inc. | 1991-04-19 | Traditional | PDF ↗ |
| K905045 | NERVE LOCATOR/STIMULATOR | Aaron Medical Industries | 1991-03-15 | Traditional | PDF ↗ |
| K894930 | DENTEC 4000 | Dentec, Inc. | 1990-03-27 | Traditional | PDF ↗ |
| K895838 | BRACKMANN EMG MONITORING SYSTEM | Wr Medical Electronics Co. | 1990-03-27 | Traditional | PDF ↗ |
| K895676 | HEMOSTAT/STIMULATOR PROBE | Rln Systems, Inc. | 1989-12-08 | Traditional | PDF ↗ |
| K881757 | RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS | Downs Surgical , Ltd. | 1988-07-15 | Traditional | PDF ↗ |
| K874018 | NEUROPROBE | Inovx, Inc. | 1988-06-01 | Traditional | PDF ↗ |
| K880720 | MONTGOMERY NERVE STIMULATOR | Boston Medical Products, Inc. | 1988-05-20 | Traditional | PDF ↗ |
| K873964 | NICOLET DISPOSABLE PRASS PROBE | Nicolet Biomedical Instruments | 1987-11-20 | Traditional | PDF ↗ |
| K872791 | POREX NERVE LOCATOR | Porex Medical | 1987-10-20 | Traditional | PDF ↗ |
| K870272 | MODEL 6110C OTOPHOR | Life-Tech Intl., Inc. | 1987-08-05 | Traditional | PDF ↗ |
| K843226 | EVOKED RESPONSE ELECTRICAL STIMULATOR | Nucleus, Ltd. | 1985-05-21 | Traditional | PDF ↗ |
| K833646 | PULSATRON NERVE LOCATOR/STIMULATOR | Edward Weck, Inc. | 1984-02-10 | Traditional | PDF ↗ |
| K831715 | NEUROTRAC | Hdc Corp. | 1983-07-07 | Traditional | PDF ↗ |
| K781569 | NERVE LOCATER/STIMULATOR | Intermedics, Inc. | 1978-12-07 | Traditional | PDF ↗ |
Product code ETN · Class II · Ear, Nose, Throat. Data: openFDA.