K081733 is an FDA 510(k) clearance for the 10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890. This device is classified as a Stents, Drains And Dilators For The Biliary Ducts (Class II - Special Controls, product code FGE).
Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on October 27, 2008, 130 days after receiving the submission on June 19, 2008.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K081733 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 2008 |
| Decision Date | October 27, 2008 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGE — Stents, Drains And Dilators For The Biliary Ducts |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |