Cuffix
510(k) K192611
Cuffix is a medical device (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, 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 | NumberK192611 | Date13 Aug 2020 | StatusActive |
Official records
- FDA 510(k) database K192611
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BSK
- FDA applicant
- Biovo Technologies , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5750
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K192611
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Cuffix 01 | 01 | 07290017345017 | — | No longer on the market |
| Cuffix 02 | 02 | 07290017345031 | — | On the market |
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