Home / 510(k) Clearances / K200759

510(k) K200759

NIM Vital, Nerve Integrity Monitor by Medtronic Xomed, Inc. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2020
Date Received
March 24, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Evoked Response
Device Class
Class II
Regulation Number
882.1870
Review Panel
NE
Submission Type

Other clearances by Medtronic Xomed, Inc.

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

  • K252842 — SafeOp 3: Neural Informatix System (January 11, 2026)
  • K243982 — Nicolet EDX (January 22, 2025)
  • K243495 — Natus Ultrapro S100 (982A0594) (December 12, 2024)
  • K242345 — Delphi Stimulator (November 5, 2024)
  • K234092 — SafeOp 3: Neural Informatix Systeem (April 19, 2024)
  • K234080 — MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) (March 25, 2024)
  • K233292 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (October 27, 2023)
  • K230415 — Cadwell Guardian (August 17, 2023)
  • K213849 — SafeOp 2: Neural Informatix System (March 9, 2022)
  • K212166 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (January 7, 2022)