K-number	K233837
Device name	Agile Esophageal Stent System
Applicant	Boston Scientific Corporation
Product code	ESW
Device class	Class II
Decision date	Apr 4, 2024
Decision	Substantially Equivalent
Regulation	878.3610

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Source

View the full FDA submission: accessdata.fda.gov

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Agile Esophageal Stent System

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