Submission Details
| 510(k) Number | K031197 FDA.gov |
| FDA Decision | Cleared SESU |
| Date Received | April 16, 2003 |
| Decision Date | June 16, 2003 |
| Days to Decision | 61 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
Cleared
Special
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Jun 2003
Decision
61d
Days
Class 2
Risk
About This 510(k) Submission
K031197 is an FDA 510(k) clearance for the MODIFICATION TO SMART CONTROL 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 June 16, 2003, 61 days after receiving the submission on April 16, 2003. 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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