Flexstent Biliary Self Expanding Stent System; S.M.A.R.T. Re-Flex Biliary Elf-Expanding Stent System
FDA 510(k) K130981 · Cordis Corp.
510(k) numberK130981
Submission
- Device name
- Flexstent Biliary Self Expanding Stent System; S.M.A.R.T. Re-Flex Biliary Elf-Expanding Stent System
- Applicant
- Cordis Corp.
Fremont, CA, US - Received
- April 9, 2013
- Decision date
- March 12, 2014
- Decision
- Unknown (SESU)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FGE – Stents, Drains And Dilators For The Biliary Ducts
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5010
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
- Life-sustaining
- Yes
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Questions and answers
When was Flexstent Biliary Self Expanding Stent System; S.M.A.R.T. Re-Flex Biliary Elf-Expanding Stent System cleared by the FDA?
Flexstent Biliary Self Expanding Stent System; S.M.A.R.T. Re-Flex Biliary Elf-Expanding Stent System (K130981) received a 510(k) decision of Unknown on March 12, 2014, 337 days after the submission was received.
What is the product code of K130981?
The FDA product code is FGE – Stents, Drains And Dilators For The Biliary Ducts, a Class II (moderate risk) device regulated under 21 CFR 876.5010.