WILSON-COOK ZILVER BILIARY STENT
FDA 510(k) clearance K020788 · decided 2002-05-08
Clearance details
- K-number
- K020788
- Device name
- WILSON-COOK ZILVER BILIARY STENT
- Applicant
- Wilson-Cook Medical, Inc.
- Decision
- Unknown
- Date received
- 2002-03-11
- Decision date
- 2002-05-08
- Days to decision
- 58 days
- Clearance type
- Special
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Winston-Salem, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm, Stent Leng recall (Z-0113-2009) | Cook Endoscopy | 2008-10-14 |
| ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent Lengt recall (Z-0089-04) | Wilson-Cook Medical Inc | 2003-11-06 |
| Zilver Expandable Metal Biliary Stent recall (Z-1181-03) | Wilson-Cook Medical Inc | 2003-08-26 |