K033537 is an FDA 510(k) clearance for the SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005. This device is classified as a Stents, Drains And Dilators For The Biliary Ducts (Class II - Special Controls, product code FGE).
Submitted by Abbott Laboratories (Redwood, US). The FDA issued a Cleared decision on December 10, 2003, 30 days after receiving the submission on November 10, 2003.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K033537 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | November 10, 2003 |
| Decision Date | December 10, 2003 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |