K251672 is an FDA 510(k) clearance for the NIM Essence™ EMG Endotracheal Tube (NIMEID060). This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on February 10, 2026, 256 days after receiving the submission on May 30, 2025.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K251672 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2025 |
| Decision Date | February 10, 2026 |
| Days to Decision | 256 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETN — Stimulator, Nerve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1820 |