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Shiley 80FXLTCD

by Covidien LP

Ref 80FXLTCD

Shiley 80FXLTCD is a device classified as Class IIb in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 20 Aug 2026 (Basic UDI-DI 0763000B00028658Y), cleared under FDA 510(k) K251313 on 29 Dec 2025 and listed in FDA GUDID since 16 Mar 2026 (UDI-DI 10884521841710), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K251313

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00028658Y Basic UDI-DI 10884521841710UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521841710 UDI-DI Date16 Mar 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK251313 Date29 Dec 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00028658Y registered 20 Aug 2026 Active
  • FDA 510(k) K251313 decided 29 Dec 2025 Active
  • FDA GUDID UDI-DI 10884521841710 listed 16 Mar 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K251313
  2. Listed FDA GUDID 10884521841710
  3. Registered EUDAMED 0763000B00028658Y

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Shiley
Generic name
Tracheostomy tube, non-reinforced, non-customized, single-use
Device name
ShileyAdultFlexibleTracheostomyTubeXLT
Model / reference
80FXLTCD
Primary DI / UDI-DI
10884521841710
Basic UDI-DI
0763000B00028658Y
510(k) Number
FDA product code
JOH
EMDN code
R0105020101 Tracheostomic cannulas, cuffed, not reinforced, with fixed flange, and kits
GMDN term
Tracheostomy tube, non-reinforced, non-customized, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.5800
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Length — 105 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K251313)

and 8 more cleared under K251313

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 (20, all answered No)