K233837
- 510(k) number
- K233837
- Device name
- Agile Esophageal Stent System
- Applicant
- Boston Scientific Corporation MA · US
- Product code
- ESW — Prosthesis, Esophageal
- Decision date
- 2024-04-04
- Date received
- 2023-12-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K233837.pdf
Official FDA record: K233837
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.