Submission Details
| 510(k) Number | K030409 FDA.gov |
| FDA Decision | Cleared SESU |
| Date Received | February 07, 2003 |
| Decision Date | March 10, 2003 |
| Days to Decision | 31 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
Cleared
Special
SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM
Mar 2003
Decision
31d
Days
Class 2
Risk
About This 510(k) Submission
K030409 is an FDA 510(k) clearance for the SMART NITINOL STENT ENDOSCOPIC 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 March 10, 2003, 31 days after receiving the submission on February 7, 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
Similar Devices — FGE Stents, Drains And Dilators For The Biliary Ducts
All 471
K253987 · GIE Medical
· Mar 2026
K253132 · Zhejiang Chuangxiang Medical Technology Co., Ltd.
· Mar 2026
K251123 · Taewoong Medical Co., Ltd.
· Dec 2025
K251019 · Bioteque Corporation
· Dec 2025
K250409 · Olympus Medical Systems Corporation
· Oct 2025
K251229 · Softac Medical Technologies
· Aug 2025
More from Cordis Corp.
View all
K130981
· FGE · Mar 2014
K112797
· LIT · May 2012
K101651
· NTE · Jul 2010
K082143
· PDU · Aug 2008
K062798
· FGE · Feb 2008