FDA 510(k)

WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System

Número K: K261978 · 2026-07-10

Data da decisão2026-07-10

Código do produtoESW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2026-07-10 under 510(k) number K261978. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System?

WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System is a medical device that received FDA 510(k) clearance on 2026-07-10. The listed applicant is Boston Scientific Corporation. The 510(k) number is K261978.

When did WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System receive FDA 510(k) clearance?

WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System received FDA 510(k) clearance on 2026-07-10, under 510(k) number K261978.

Who is the listed applicant for WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System?

The FDA product code for WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System is ESW.

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Fonte oficial

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