K172720 is an FDA 510(k) clearance for the TRACOE silcosoft Tracheostomy Tube. This device is classified as a Tube Tracheostomy And Tube Cuff (Class II - Special Controls, product code JOH).
Submitted by Tracoe Medical GmbH (Nieder-Olm, DE). The FDA issued a Cleared decision on April 27, 2018, 231 days after receiving the submission on September 8, 2017.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K172720 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2017 |
| Decision Date | April 27, 2018 |
| Days to Decision | 231 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 |