K012883 is an FDA 510(k) clearance for the ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM. This device is classified as a Prosthesis, Esophageal (Class II - Special Controls, product code ESW).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on October 12, 2001, 45 days after receiving the submission on August 28, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K012883 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | August 28, 2001 |
| Decision Date | October 12, 2001 |
| Days to Decision | 45 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 |