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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 the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2021-11-22 under 510(k) 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. The listed applicant is Boston Scientific Corporation. The 510(k) number is K211960.

When did Agile Esophageal OTW Stent System receive FDA 510(k) clearance?

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

Who is the listed applicant for Agile Esophageal 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 Agile Esophageal OTW Stent System?

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

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Other records listing Boston Scientific Corporation as applicant

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Related Devices (Code: ESW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific CorporationK253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.K251265Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc.K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston ScientificK233837Agile Esophageal Stent SystemBoston Scientific Corporation

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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