NIM Essence
NIM Essence is an endotracheal tube that provides an airway for ventilation while recording electrical activity from the laryngeal muscles during surgery. It connects to a compatible EMG…
NIM Essence is an endotracheal tube that provides an airway for ventilation while recording electrical activity from the laryngeal muscles during surgery. It connects to a compatible EMG nerve-monitoring system.
The tube is reinforced PVC with an inflatable cuff. Flexible printed-circuit electrodes wrap around the shaft beneath a silicone cover, with a short exposed section positioned above the cuff to contact tissue near the vocal cords.
Listed Item
Essence EMG Tube NIMEID075 5PK 7.5MM CE
Monitoring Configuration
The electrodes connect the laryngeal muscle signals to the monitor. NIM 3.0 and NIM Vital are recommended compatible systems. The tube is supplied sterile for single use and is intended for intraoperative monitoring where the nerves supplying the laryngeal muscles need observation; it is not intended for postoperative use.
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (2), Guangdong (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Ningbo Shun YE Medical Company, Ltd. | Cixi Ningbo | Zhejiang | Contract manufacturer | 8 |
| Shenzhen Launch Electrical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Changzhou Emanmed Biotechnology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | Medtronic Xomed, Inc., United States |
|---|---|
| FDA product code | ETN |
| Device type | Stimulator, Nerve |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1820 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K251672 |
| Record published | 2026-06-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Storage | Special storage condition: Stay away from light; Handling environment temperature 10 to 30 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 10 to 70 % RH |
| Packaging | Pack of 5 |
| Sizes | Outer diameter 8.5 to 10.9 mm; lumen/inner diameter 6 to 8 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NIMEID075 | Outer Diameter 10.3 mm | In distribution |
| NIMEID080 | Lumen/Inner Diameter 8.0 mm | In distribution |
| NIMEID070 | Lumen/Inner Diameter 7.0 mm | In distribution |
| NIMEID060 | Outer Diameter 8.5 mm | In distribution |
| NIMEID065 | Lumen/Inner Diameter 6.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 226 |
| Stimulator, Nerve | Medtronic Xomed, Inc. | 125 |
| MaXcess | Nuvasive, Inc. | 95 |
| Armada | Nuvasive, Inc. | 67 |
| Stimulator, Nerve | Neurovision Medical Products, Inc. | 47 |
| Precept | Nuvasive, Inc. | 39 |
| MAS Plif | Nuvasive, Inc. | 36 |
| NIM | Medtronic Xomed, Inc. | 34 |
| Nerveana® | Neurovision Medical Products, Inc. | 30 |
| SpheRx | Nuvasive, Inc. | 30 |
| IOM Stimulator Probes | Spes Medica Srl | 29 |
| NVM5 | Nuvasive, Inc. | 25 |
Showing 12 of 119. All products under Stimulator, Nerve
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251672 | 2026-02-10 |
| K230320 | 2023-10-26 |
| K231580 | 2023-08-30 |
| K213246 | 2022-03-21 |
| K112686 | 2012-06-27 |
| K063305 | 2006-11-29 |
| K050162 | 2005-03-03 |
| K031510 | 2003-06-18 |
| K031003 | 2003-04-11 |
| K014165 | 2002-01-22 |
Recalls
4 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-11-07 | Class II | Under Investigation by firm | Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring, | 80569 units | |
| 2022-04-29 | Class I | Under Investigation by firm | The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes. | 23,820 units | |
| 2022-04-29 | Class I | Under Investigation by firm | The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes. | 81,555 units | |
| 2022-04-29 | Class I | Under Investigation by firm | The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes. | 1,133,612 units | |
| 2021-12-22 | Class II | Process control | There is potential for multiple issues due to a manufacturing nonconformity. | 301,926 devices | |
| 2016-06-28 | Class II | Use error | Wire in tubing can become exposed, posing potential harm to the intubated patient. | 3752 | 2019-08-07 |
| 2013-03-04 | Class I | Use error | In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in the intraoperative cuff deflation which then requires re-inflation or replacement of the deflated tube in order to ensure the contin | 2,591 units | 2014-01-30 |
| 2008-11-21 | Not classified | Employee error | Device may fail to operate or operate intermittently during use and such operation could result in a lack of nerve stimulation when nerve tissue is actually contacted by the stimulator. | 22 boxes (220 units) | 2009-10-01 |
| 2004-10-29 | Not classified | Other | The firm received six reports of tubes with wires ‘out of channel’ two of which involved injuried patients. In one case in Germany it was reported that the patient had soreness of the throat and was discharged after four days. In the next c | 22569 EMG Tubes | 2012-07-07 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.