K192611 is an FDA 510(k) clearance for the Cuffix. This device is classified as a Cuff, Tracheal Tube, Inflatable (Class II - Special Controls, product code BSK).
Submitted by Biovo Technologies , Ltd. (Rosh Haayin, IL). The FDA issued a Cleared decision on August 13, 2020, 328 days after receiving the submission on September 20, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5750.
| 510(k) Number | K192611 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2019 |
| Decision Date | August 13, 2020 |
| Days to Decision | 328 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BSK - Cuff, Tracheal Tube, Inflatable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5750 |