510(k) K261978 ยท ESW Prosthesis, Esophageal
WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Jul 10, 2026 |
| Received | Jun 12, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261978
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.