K243126 is an FDA 510(k) clearance for the TRACHEOBRONXANE? DUMON?. This device is classified as a Prosthesis, Tracheal, Preformed/molded (Class II - Special Controls, product code NWA).
Submitted by Novatech SA (La Ciotat Cedex, FR). The FDA issued a Cleared decision on October 29, 2024, 29 days after receiving the submission on September 30, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 878.3720. The Device Is Intended To Provide Support To Weakened Or Constricting Airway Walls..
| 510(k) Number | K243126 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2024 |
| Decision Date | October 29, 2024 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | NWA — Prosthesis, Tracheal, Preformed/molded |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3720 |
| Definition | The Device Is Intended To Provide Support To Weakened Or Constricting Airway Walls. |