Shiley 110860
Shiley 110860 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 10884521853812), active as of 9 Nov 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10884521853812 | Date25 Oct 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK082520 | Date2 Oct 2008 | StatusActive |
Official records
- AccessGUDID record 10884521853812
- FDA 510(k) database K082520
Across registries
- FDA 510(k) K082520 decided 2 Oct 2008 Active
- FDA GUDID UDI-DI 10884521853812 listed 25 Oct 2026 Listed
Recalls
-
- Terminated Z-1626-2016
- Terminated Z-1625-2016
Device packaging may not be sealed.
Timeline
- Cleared FDA 510(k) K082520
- Recall initiated FDA recalls Z-1626-2016
- Recall initiated FDA recalls Z-1625-2016
- Listed FDA GUDID 10884521853812
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Shiley
- Generic name
- Basic endotracheal tube, single-use
- Model / reference
- 110860
- Primary DI / UDI-DI
- 10884521853812
- 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