Home / 510(k) Clearances / K251672

510(k) K251672

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) by Medtronic Xomed, Inc. — Product Code ETN

K251672 is an FDA 510(k) premarket notification submitted by Medtronic Xomed, Inc. for the device "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)". The FDA issued a decision of Substantially Equivalent on February 10, 2026. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Medtronic Xomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2026
Date Received
May 30, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve
Device Class
Class II
Regulation Number
874.1820
Review Panel
EN
Submission Type

Other clearances by Medtronic Xomed, Inc.

  • K230320 — NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotrache (October 26, 2023)
  • K231580 — NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) (August 30, 2023)
  • K213246 — NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, N (March 21, 2022)
  • K210841 — NuVent Eustachian Tube Dilation Balloon (August 16, 2021)
  • K202623 — Novapak Nasal Sinus Packing and Stent (December 8, 2020)
  • K200759 — NIM Vital, Nerve Integrity Monitor (October 28, 2020)
  • K173855 — Sharpsite AC Rigid Endsocope (April 20, 2018)
  • K152121 — NuVent EM Sinus Dilation System (December 1, 2015)
  • K151758 — ALAR Nasal Valve Stent (October 29, 2015)
  • K150728 — XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole (August 14, 2015)

Other clearances for product code ETN

  • K253536 — Evala Nerve Stimulator (EPNR002) (February 27, 2026)
  • K242852 — ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM (June 13, 2025)
  • K233001 — Bioscope Neuromonitor Device (December 13, 2024)
  • K241917 — EARP Nerve Cuff Electrode (July 31, 2024)
  • K232888 — Disposable Laryngeal Electrodes (December 21, 2023)
  • K230320 — NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotrache (October 26, 2023)
  • K230853 — EARP Nerve Cuff Electrode (October 6, 2023)
  • K231580 — NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) (August 30, 2023)
  • K223254 — C2 Xplore (January 27, 2023)
  • K212164 — Mapping Suction Probe (November 11, 2022)

FDA data resources