K202204 is an FDA 510(k) clearance for the Tracheal Stent System. This device is classified as a Prosthesis, Tracheal, Expandable (Class II - Special Controls, product code JCT).
Submitted by Micro-Tech (Nanjing) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on September 1, 2021, 392 days after receiving the submission on August 5, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 878.3720.
| 510(k) Number | K202204 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2020 |
| Decision Date | September 01, 2021 |
| Days to Decision | 392 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 |