K111611 is an FDA 510(k) clearance for the ENDOMAXX FULLY COVERED ESOPHAGEAL STENT. This device is classified as a Prosthesis, Esophageal (Class II - Special Controls, product code ESW).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on July 29, 2011, 50 days after receiving the submission on June 9, 2011.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K111611 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2011 |
| Decision Date | July 29, 2011 |
| Days to Decision | 50 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 |