K072094 is an FDA 510(k) clearance for the CHOOSTENT. This device is classified as a Prosthesis, Esophageal (Class II - Special Controls, product code ESW).
Submitted by M.I. Tech Co., Ltd. (Deerfield, US). The FDA issued a Cleared decision on September 25, 2008, 423 days after receiving the submission on July 30, 2007.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K072094 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2007 |
| Decision Date | September 25, 2008 |
| Days to Decision | 423 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 |