FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
FDA 510(k) clearance K121125 · decided 2012-07-06
Clearance details
- K-number
- K121125
- Device name
- FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
- Applicant
- Flexible Stenting Solutions, Inc.
- Decision
- Unknown
- Date received
- 2012-04-13
- Decision date
- 2012-07-06
- Days to decision
- 84 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
No recalls on record reference this clearance.