FDA 510(k)

Evolution Esophageal Stent System – Partially Covered

Numéro K : K162717 · 2016-12-21

Date de décision2016-12-21

Code produitESW

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Evolution Esophageal Stent System – Partially Covered is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K162717. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Evolution Esophageal Stent System – Partially Covered?

Evolution Esophageal Stent System – Partially Covered is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K162717.

When did Evolution Esophageal Stent System – Partially Covered receive FDA 510(k) clearance?

Evolution Esophageal Stent System – Partially Covered received FDA 510(k) clearance on 2016-12-21, under 510(k) number K162717.

Who is the listed applicant for Evolution Esophageal Stent System – Partially Covered?

The FDA 510(k) record lists Cook Ireland, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Evolution Esophageal Stent System – Partially Covered?

The FDA product code for Evolution Esophageal Stent System – Partially Covered is ESW.

Essais cliniques associés

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Autres dossiers indiquant Cook Ireland, Ltd. en tant que demandeur

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Dispositifs connexes (Code : ESW)

K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation K253327HANAROSTENT 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 Scientific K233837Agile Esophageal Stent SystemBoston Scientific Corporation

Source officielle

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