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Well Lead Endobronchial Tubes

by Well Lead Instruments

510(k) K092886

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 NumberK092886 Date11 Mar 2010ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1399-2017 FDA Class II initiated 16 Dec 2016

    The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended.

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  • Withdrawn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
CBI
Device Class
Class II
Regulation
21 CFR Part 868.5740
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent