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Neurovision Ink Printed Endotracheal Tube Electrode

by Neurovision Medical Products, Inc. 2 variants

510(k) K110989

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK110989 Date3 Nov 2011ClearedStatusActive

Recalls

10 recalls · 1 ongoing · FDA

    • Ongoing Z-2719-2024 FDA Class II initiated 1 Jul 2024

    mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size.

  • 9 recalls, same reason

    • Terminated Z-2900-2020 FDA Class II initiated 21 Jul 2020
    • Terminated Z-2905-2020 FDA Class II initiated 21 Jul 2020
    • Terminated Z-2904-2020 FDA Class II initiated 21 Jul 2020
    • Terminated Z-2907-2020 FDA Class II initiated 21 Jul 2020
    • Terminated Z-2903-2020 FDA Class II initiated 21 Jul 2020
    • Terminated Z-2901-2020 FDA Class II initiated 21 Jul 2020
    • Terminated Z-2906-2020 FDA Class II initiated 21 Jul 2020
    • Terminated Z-2902-2020 FDA Class II initiated 21 Jul 2020
    • Terminated Z-2908-2020 FDA Class II initiated 21 Jul 2020

    The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ETN
Device Class
Class II
Regulation
21 CFR Part 874.1820
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

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