K093537 is an FDA 510(k) clearance for the HANAROSTENT ESOPHAGUS (CCC). This device is classified as a Prosthesis, Esophageal (Class II - Special Controls, product code ESW).
Submitted by M.I. Tech Co., Ltd. (Buena Park, US). The FDA issued a Cleared decision on June 4, 2010, 200 days after receiving the submission on November 16, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K093537 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2009 |
| Decision Date | June 04, 2010 |
| Days to Decision | 200 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 |