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510(k) K230320

NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube by Medtronic Xomed, Inc. — Product Code ETN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2023
Date Received
February 6, 2023
Clearance Type
Special
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.

  • K251672 — NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tu (February 10, 2026)
  • 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)
  • K251672 — NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tu (February 10, 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)
  • 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)