WallFlex Biliary PLUS RX Stent System
FDA 510(k) clearance K242950 · decided 2024-12-06
Clearance details
- K-number
- K242950
- Device name
- WallFlex Biliary PLUS RX Stent System
- Applicant
- Boston Scientific
- Decision
- Unknown
- Date received
- 2024-09-23
- Decision date
- 2024-12-06
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.