K021994 is an FDA 510(k) clearance for the BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM. This device is classified as a Stents, Drains And Dilators For The Biliary Ducts (Class II - Special Controls, product code FGE).
Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on January 2, 2003, 198 days after receiving the submission on June 18, 2002.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K021994 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | June 18, 2002 |
| Decision Date | January 02, 2003 |
| Days to Decision | 198 days |
| Submission Type | Abbreviated |
| 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 |