FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
FDA 510(k) clearance K081996 · decided 2009-09-15
Clearance details
- K-number
- K081996
- Device name
- FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
- Applicant
- Flexible Stenting Solutions, Inc.
- Decision
- Unknown
- Date received
- 2008-07-14
- Decision date
- 2009-09-15
- Days to decision
- 428 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Eatontown, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SE recall (Z-1507-2013) | Cordis Corporation | 2013-06-06 |