K091510 is an FDA 510(k) clearance for the WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730. This device is classified as a Prosthesis, Esophageal (Class II - Special Controls, product code ESW).
Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on June 26, 2009, 35 days after receiving the submission on May 22, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K091510 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2009 |
| Decision Date | June 26, 2009 |
| Days to Decision | 35 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 |