K093947 is an FDA 510(k) clearance for the ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC. This device is classified as a Stents, Drains And Dilators For The Biliary Ducts (Class II - Special Controls, product code FGE).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on January 21, 2010, 29 days after receiving the submission on December 23, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K093947 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | December 23, 2009 |
| Decision Date | January 21, 2010 |
| Days to Decision | 29 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 |