K201160 is an FDA 510(k) clearance for the HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN). This device is classified as a Prosthesis, Esophageal (Class II - Special Controls, product code ESW).
Submitted by M.I. Tech Co., Ltd. (Pyeongtaek-Si, KR). The FDA issued a Cleared decision on July 23, 2021, 449 days after receiving the submission on April 30, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K201160 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2020 |
| Decision Date | July 23, 2021 |
| Days to Decision | 449 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ESW - Prosthesis, Esophageal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3610 |