Medtronic Xomed, Inc. · Class II · Cleared Feb 10, 2026
| K-number | K251672 |
| Device name | 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) |
| Applicant | Medtronic Xomed, Inc. |
| Product code | ETN |
| Device class | Class II |
| Decision date | Feb 10, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 874.1820 |
The NIM Essence™ EMG Endotracheal Tube is a flexible, reinforced PVC tube with an inflatable cuff used during surgery to provide an open airway and continuously monitor nerve activity in the laryngeal muscles. It contains electrodes that contact the vocal cord area to facilitate electromyographic monitoring when connected to an EMG monitoring device, and is not intended for postoperative use.
The subject device uses a Flexible Printed Circuit (FPC) with flexible printed carbon overprint electrodes and stainless steel reinforcement, compared to the predicate's conductive silver ink electrodes and no reinforcement. The subject device has a 3-year shelf life versus the predicate's 4-year shelf life and a narrower tube inner diameter range (6–8 mm vs. 5–9 mm). Both are PVC tubes with PVC cuffs, 4 laryngeal electrodes, EtO sterilization, and limited use under 24 hours.
ISO 10993-1 and ISO 18562-1 (biocompatibility), ISO 11135 (EO sterilization), ANSI/AAMI ES 60601-1/IEC 60601-1 (electrical safety), IEC 60601-1-2 and IEC TS 60601-4-2 (electromagnetic compatibility), IEC 62366-1 (usability), IEC 60601-1-6 (general requirements), and ISO 5361 (endotracheal tube performance).
View the full FDA submission: accessdata.fda.gov