K201342 is an FDA 510(k) clearance for the HANAROSTENT Trachea/Bronchium (CCC). This device is classified as a Prosthesis, Tracheal, Expandable (Class II - Special Controls, product code JCT).
Submitted by M.I. Tech Co., Ltd. (Pyeongtaek-Si, KR). The FDA issued a Cleared decision on December 31, 2020, 225 days after receiving the submission on May 20, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 878.3720.
| 510(k) Number | K201342 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2020 |
| Decision Date | December 31, 2020 |
| Days to Decision | 225 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | JCT - Prosthesis, Tracheal, Expandable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3720 |