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)

FDA cleared the 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) from Medtronic Xomed, Inc. on Feb 10, 2026 under K251672, a traditional 510(k). The device falls under product code ETN, Stimulator, Nerve, regulated at 21 CFR 874.1820 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on May 30, 2025. The decision came 256 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medtronic Xomed, Inc. has one other decision in the tracker over the last 12 months: K262235 (ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCut ™ Blade with Automated EM Tracking (187BL4060EM);ApexCut ™ Blade with Automated EM Tracking (187BL2975EM);ApexCut ™ Blade with Automated EM Tracking (187BL3590EM);ApexCut ™ Blade with Automated EM Tracking (187BL4000LEM)).