510(k) K223592
K223592 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers". The FDA issued a decision of Substantially Equivalent on Dec 29, 2022. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Boston Scientific Corporation has 238 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 29, 2022
- Date Received
- Dec 1, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stents, Drains And Dilators For The Biliary Ducts
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type
- 510(k)