Tracheotomy Tubes
510(k) K781729
Tracheotomy Tubes is a Class II device made by Tracoe medical GmbH, cleared under FDA 510(k) K781729 on 24 Oct 1978, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781729 | Date24 Oct 1978 | StatusActive |
Official records
- FDA 510(k) database K781729
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BTO
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5800
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent