K213251 is an FDA 510(k) clearance for the HANAROSTENT Esophagus Asymmetric (CCC), 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 November 18, 2021, 49 days after receiving the submission on September 30, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K213251 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 30, 2021 |
| Decision Date | November 18, 2021 |
| Days to Decision | 49 days |
| Submission Type | Special |
| 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 |