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FDA 510(k)

Evolution Esophageal Stent System – Partially Covered

K-Number: K162717 · 2016-12-21

ApplicantCook Ireland, Ltd.
Decision Date2016-12-21
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Evolution Esophageal Stent System – Partially Covered is a medical device manufactured by Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2016-12-21 under approval number K162717. 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 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. It is manufactured by Cook Ireland, Ltd.. The 510(k) number is K162717.

When was Evolution Esophageal Stent System – Partially Covered approved by the FDA?

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

What company makes Evolution Esophageal Stent System – Partially Covered?

Evolution Esophageal Stent System – Partially Covered is manufactured by Cook Ireland, Ltd..

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.

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Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

Other Devices by Cook Ireland, Ltd.

K163018Zilver 635 Biliary Stent K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle K17161914Fr Colon Decompression Set, Macon Colon Decompression Set K171623Nasal Pancreatic Drainage Set K163468Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered K163169Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent

View all 19 devices →

Related Devices (Code: ESW)

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. K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation 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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