K234046
- 510(k) number
- K234046
- Device name
- WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
- Applicant
- Boston Scientific Corporation MA · US
- Product code
- MQR — Stent, Colonic, Metallic, Expandable
- Decision date
- 2024-03-08
- Date received
- 2023-12-21
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K234046.pdf
Official FDA record: K234046
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.