K182743 is an FDA 510(k) clearance for the Patient-Specific Airway Stent. This device is classified as a Prosthesis, Tracheal, Preformed/molded (Class II - Special Controls, product code NWA).
Submitted by New Cos, Inc. (Cleveland, US). The FDA issued a Cleared decision on October 23, 2019, 390 days after receiving the submission on September 28, 2018.
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 | K182743 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2018 |
| Decision Date | October 23, 2019 |
| Days to Decision | 390 days |
| Submission Type | Traditional |
| 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. |