Cuffix 02
Cuffix 02 is an endotracheal tube cuff inflator (FDA Class II; FDA product code BSK, Cuff, Tracheal Tube, Inflatable) made by Biovo Technologies, Ltd., cleared under FDA 510(k) K192611 on 13 Aug 2020 and listed in FDA GUDID since 3 Jan 2021 (UDI-DI 07290017345031), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290017345031 | Date3 Jan 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192611 | Date13 Aug 2020 | StatusActive |
Official records
- AccessGUDID record 07290017345031
- FDA 510(k) database K192611
Across registries
- FDA 510(k) K192611 decided 13 Aug 2020 Active
- FDA GUDID UDI-DI 07290017345031 listed 3 Jan 2021 Listed
Timeline
- Cleared FDA 510(k) K192611
- Listed FDA GUDID 07290017345031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cuffix
- Generic name
- Endotracheal tube cuff inflator
- Model / reference
- 02
- Primary DI / UDI-DI
- 07290017345031
- 510(k) Number
- FDA product code
- BSK
- GMDN term
- Endotracheal tube cuff inflator
- Device class
- Class II
- Regulation number
- 868.5750
- GUDID distribution status
- In Commercial Distribution
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