510(k) K230320
- Device
- NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
- Applicant
- Medtronic Xomed, Inc.
- 510(k) number
- K230320
- Product code
- ETN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-10-26
- Date received
- 2023-02-06
- Regulation
- 874.1820
- Classification name
- Stimulator, Nerve
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Alexandra Oliver
- Address
- 6743 Southpoint Dr. N. Jacksonville FL US 32216 32216
FDA Registration Numbers
- 1000200989
- 3013480096
- 9710376
- 1412854
- 3006639944
- 3020706315
- 2134470
- 3010057495
- 1052728
- 3004464325
- 2132111
- 3007770159
- 2183744
- 3010041430
- 2183946
- 3023852420
- 1824199
- 2032098
- 3004598644
- 1052723
- 1833920
- 3025603301
- 3004753785
- 2031093
- 3011050570
- 3010209365
- 2246552
- 3003851073
- 2133772
- 1721676
- 2532027
- 3007713076
- 1064858
- 3017210488
- 3009103001
- 3017636737
- 3011534533
- 1045254
- 9611390
- 3031284747
- 3042364673
- 3016438694
- 3009973336
- 3006128100
- 3014279513
- 3003935342
- 1030489
- 3012263546
- 3030412764
- 3008102049
- 2031966
- 3010611950
- 3010120135
- 3009417901
- 3008573567
- 3013485140
- 3004024955
- 3000270450
- 1928237
- 1526534
- 1319639
- 1828288
- 9680837
- 1930870
- 1061927
- 8021774
- 1056553
- 3009888740
- 3006697681
- 3003477135
- 3023164
- 3003120897
- 3021632375
- 3020018
- 3007207906
- 3005497913
- 1218017
- 3010047454
- 2134947
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code ETN
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253536 | Evala Nerve Stimulator (EPNR002) | Epineuron Technologies, Inc. | 2026-02-27 |
| 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 |
| 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 |
| K233001 | Bioscope Neuromonitor Device | Biosys Biyomedikal Muhendislik San. VE Tic. A.S. | 2024-12-13 |
| K241917 | EARP Nerve Cuff Electrode | Retropsoas Technologies, LLC | 2024-07-31 |
| K232888 | Disposable Laryngeal Electrodes | Suzhou Haishen Medical Device Associates Co., Ltd. | 2023-12-21 |
| K230853 | EARP Nerve Cuff Electrode | Nvision Biomedical Technologies, Inc. | 2023-10-06 |
| K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) | Medtronic Xomed, Inc. | 2023-08-30 |
| K223254 | C2 Xplore | Inomed Medizintechnik GmbH | 2023-01-27 |
| K212164 | Mapping Suction Probe | Inomed Medizintechnik GmbH | 2022-11-11 |
| 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 |
| K212355 | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large | Checkpoint Surgical | 2021-08-26 |
| K200886 | StimSite | Allotrope Medical, Inc. | 2020-11-10 |
| K152769 | FREMAP ELECTRODE | Ad-Tech Medical Instrument Corporation | 2016-05-06 |
| K152505 | C2 NerveMonitor System | Inomed Medizintechnik GmbH | 2016-02-01 |