K193077 is an FDA 510(k) clearance for the Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff. This device is classified as a Tube Tracheostomy And Tube Cuff (Class II - Special Controls, product code JOH).
Submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on June 1, 2020, 209 days after receiving the submission on November 5, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K193077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2019 |
| Decision Date | June 01, 2020 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | JOH — Tube Tracheostomy And Tube Cuff |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5800 |