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Shiley 110885

by Covidien LP 2 variants

Shiley 110885 is a Class II device made by Covidien LP, cleared under FDA 510(k) K082520 on 2 Oct 2008 and listed in FDA GUDID since 25 Oct 2026 (UDI-DI 10884521853867), active as of 9 Nov 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K082520

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10884521853867 UDI-DI Date25 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK082520 Date2 Oct 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K082520 decided 2 Oct 2008 Active
  • FDA GUDID UDI-DI 10884521853867 listed 25 Oct 2026 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1626-2016 FDA Class II initiated 4 Apr 2016
    • Terminated Z-1625-2016 FDA Class II initiated 4 Apr 2016

    Device packaging may not be sealed.

Timeline

4 dated events

  1. Cleared FDA 510(k) K082520
  2. Recall initiated FDA recalls Z-1626-2016
  3. Recall initiated FDA recalls Z-1625-2016
  4. Listed FDA GUDID 10884521853867

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Shiley
Generic name
Basic endotracheal tube, single-use
Model / reference
110885
Primary DI / UDI-DI
10884521853867
510(k) Number
FDA product code
BTR
GMDN term
Basic endotracheal tube, single-use
Device class
Class II
Regulation number
868.5730
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K082520)

and 8 more cleared under K082520

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)