WallFlex Esophageal Stent System; Agile Esophageal Over-the-Wire (OTW) Stent System— 510(k) K261978
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K261978 for WallFlex Esophageal Stent System; Agile Esophageal Over-the-Wire (OTW) Stent System, Substantially Equivalent on 2026-07-10. Applicant: Boston Scientific Corporation. Device class: 2.
Summary
Boston Scientific's clearance covers the WallFlex Esophageal Stent System and the Agile Esophageal Over-the-Wire (OTW) Stent System, filed under ESW, esophageal prostheses. The record doesn't give stent sizes.
Class II, 21 CFR 878.3610. The Gastroenterology and Urology review panel handled it as a Special 510(k), though the record lists General and Plastic Surgery as the classification panel.
Boston Scientific filed from Marlboro, Massachusetts. Review took 28 calendar days (June 12 to July 10, 2026).
Clearance details
- Device name as filed
- WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System
- Applicant
- Boston Scientific Corporation
- Product code
- Product code ESW
- Device class
- Class 2
- Regulation
- 21 CFR 878.3610
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Marlboro, MA, US
Recent devices under product code ESW
view allMore clearances from Boston Scientific Corporation
view allAdverse events under product code ESW
product code ESW- Death
- 11
- Injury
- 353
- Malfunction
- 442
- Total
- 806
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.