510(k) K223469
K223469 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "WallFlex Biliary RX Stent System". The FDA issued a decision of Substantially Equivalent - With Limitations on Jun 15, 2023. 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
- SESU (Substantially Equivalent - With Limitations)
- Decision Date
- Jun 15, 2023
- Date Received
- Nov 17, 2022
- Clearance Type
- Traditional
- 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)