K261978
- 510(k) number
- K261978
- Device name
- WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System
- Applicant
- Boston Scientific Corporation MA · US
- Product code
- ESW — Prosthesis, Esophageal
- Decision date
- 2026-07-10
- Date received
- 2026-06-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K261978.pdf
Official FDA record: K261978
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.