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Laryngeal Surface Electrode-Endotracheal Tube, M-500-Et, Lse-Et

by Rln Systems, Inc.

510(k) K003745

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK003745 Date16 Jan 2001ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0798-2010 FDA Unclassified (pre-2012) initiated 11 Jan 2010

    This recall has been initiated due to a conductive glue used to attach the lead wire to electrode, which has been found in a small number of electrodes, to cause a short circuit in one of the channels. This is due to migration of the adhesive from one pad to the other creating an electrical short. Use of one of these defective electrodes could lead to a failure to monitor. Our investigation has c

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  • Withdrawn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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