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FDA 510(k)

Agile Esophageal OTW Stent System

K-Number: K211960 · 2021-11-22

ApplicantBoston Scientific Corporation
Decision Date2021-11-22
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Agile Esophageal OTW Stent System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2021-11-22 under approval number K211960. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Agile Esophageal OTW Stent System?

Agile Esophageal OTW Stent System is a medical device that received FDA 510(k) clearance on 2021-11-22. It is manufactured by Boston Scientific Corporation. The 510(k) number is K211960.

When was Agile Esophageal OTW Stent System approved by the FDA?

Agile Esophageal OTW Stent System received FDA 510(k) clearance on 2021-11-22, under approval number K211960.

What company makes Agile Esophageal OTW Stent System?

Agile Esophageal OTW Stent System is manufactured by Boston Scientific Corporation.

What is the FDA product code for Agile Esophageal OTW Stent System?

The FDA product code for Agile Esophageal OTW Stent System is ESW.

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Related Devices (Code: ESW)

K162717Evolution Esophageal Stent System – Partially CoveredCook Ireland, Ltd. K180144Agile Esophageal Stent SystemBoston Scientific Corporation K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. K182910Segmented Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)M.I.Tech Co., Ltd. K213251HANAROSTENT Esophagus Asymmetric (CCC)M.I.Tech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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