Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
FDA 510(k) clearance K251291 · decided 2025-07-03
Clearance details
- K-number
- K251291
- Device name
- Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
- Applicant
- Boston Scientific
- Decision
- Substantially Equivalent
- Date received
- 2025-04-25
- Decision date
- 2025-07-03
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.