Submission Details
| 510(k) Number | K130981 FDA.gov |
| FDA Decision | Cleared SESU |
| Date Received | April 09, 2013 |
| Decision Date | March 12, 2014 |
| Days to Decision | 337 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
Cleared
Traditional
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM
Mar 2014
Decision
337d
Days
Class 2
Risk
About This 510(k) Submission
K130981 is an FDA 510(k) clearance for the FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Cordis Corp. (Fremont, US). The FDA issued a Cleared decision on March 12, 2014, 337 days after receiving the submission on April 9, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.
Device Classification
| Product Code | FGE — Stents, Drains And Dilators For The Biliary Ducts |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5010 |
Manufacturer
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