K020052 is an FDA 510(k) clearance for the SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on February 11, 2002, 34 days after receiving the submission on January 8, 2002. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K020052 FDA.gov |
| FDA Decision | Cleared SESU |
| Date Received | January 08, 2002 |
| Decision Date | February 11, 2002 |
| Days to Decision | 34 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 |