K030559 is an FDA 510(k) clearance for the RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM, a Prosthesis, Esophageal (Class II — Special Controls, product code ESW), submitted by Rusch Intl. (Jaffrey, US). The FDA issued a Cleared decision on June 30, 2003, 129 days after receiving the submission on February 21, 2003. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K030559 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 21, 2003 |
| Decision Date | June 30, 2003 |
| Days to Decision | 129 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 |