510(k) K213246
- Device
- NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
- Applicant
- Medtronic Xomed, Inc.
- 510(k) number
- K213246
- Product code
- ETN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-03-21
- Date received
- 2021-09-30
- Regulation
- 874.1820
- Classification name
- Stimulator, Nerve
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Alexandra Oliver
- Address
- 6743 Southpoint Dr. N. Jacksonville FL US 32216 32216
FDA Registration Numbers#
- 3003851073
- 3014279513
- 1045254
- 3019878714
- 3014680149
- 3010709436
- 2031093
- 3006783837
- 1526534
- 3007770159
- 2024311
- 1721676
- 3003080184
- 3006128100
- 3003477135
- 3008892509
- 3009973336
- 9611390
- 2132111
- 3016678045
- 2027467
- 3011534533
- 3006849754
- 3033509898
- 2031094
- 3003120897
- 3013480096
- 2532027
- 3013485140
- 1056553
- 3007014520
- 3008114965
- 3004893332
- 3043543260
- 1037007
- 3021632375
- 3027614879
- 2011171
- 3003790304
- 1833920
- 2183744
- 3004598644
- 1211566
- 2184161
- 1220477
- 2134470
- 3017210488
- 3014479313
- 3010209365
- 9680837
- 3010120135
- 9710376
- 1000200989
- 1824199
- 3031284747
- 3012222873
- 1064858
- 1928237
- 3004024955
- 1828288
- 3010149039
- 3011050570
- 3010123206
- 3009144915
- 1450997
- 1836161
- 3009050824
- 3020706315
- 3026023106
- 3023852420
- 1030489
- 3017636737
- 3004464325
- 3009103001
- 3042364673
- 3019373845
- 3007713076
- 3024673
- 1222275
Source Documents#
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 |
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube | Medtronic Xomed, Inc. | 2023-10-26 |
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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