NIM Essence EMG Endotracheal Tube (5 models)— 510(k) K251672
Substantially EquivalentMedtronic Xomed, Inc.
FDA 510(k) clearance K251672 for NIM Essence EMG Endotracheal Tube (5 models), Substantially Equivalent on 2026-02-10. Applicant: Medtronic Xomed, Inc.. Device class: 2.
Summary
Medtronic Xomed lists the NIM Essence EMG Endotracheal Tube in five versions: NIMEID060, NIMEID065, NIMEID070, NIMEID075, and NIMEID080. It's filed under product code ETN (Stimulator, Nerve), and the record doesn't say how the five differ.
Class II, 21 CFR 874.1820. Ear, Nose, Throat is both the classification panel and the review panel. It came in as a Traditional 510(k).
Medtronic Xomed filed from Jacksonville, Florida. Review took 256 calendar days (May 30, 2025 to February 10, 2026), ending in a substantially equivalent decision.
Clearance details
- Device name as filed
- 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
- Product code ETN
- Device class
- Class 2
- Regulation
- 21 CFR 874.1820
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
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- K210841 — NuVent Eustachian Tube Dilation Balloon
Adverse events under product code ETN
product code ETN- Death
- 7
- Injury
- 327
- Malfunction
- 2,776
- Total
- 3,110
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.