K233939
- 510(k) number
- K233939
- Device name
- Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
- Applicant
- Boston Scientific MA · US
- Product code
- ESW — Prosthesis, Esophageal
- Decision date
- 2024-04-29
- Date received
- 2023-12-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K233939.pdf
Official FDA record: K233939
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.