FDA 510(k) clearance · back to tracker

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

Boston Scientific Corporation cleared K261978 on 2026-07-10, decision: substantially equivalent

K-number

K261978

Sponsor

Boston Scientific Corporation

Device

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

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-07-10

Product code

ESW

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.3610

Official FDA record

Open K261978on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.