Zilver 518 Biliary Stent
FDA 510(k) K033348 · Cook, Inc.
510(k) numberK033348
Submission
- Device name
- Zilver 518 Biliary Stent
- Applicant
- Cook, Inc.
Bloomington, IN, US - Received
- October 20, 2003
- Decision date
- December 15, 2003
- Decision
- Unknown (SESU)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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 Zilver 518 Biliary Stent cleared by the FDA?
Zilver 518 Biliary Stent (K033348) received a 510(k) decision of Unknown on December 15, 2003, 56 days after the submission was received.
What is the product code of K033348?
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.