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FDA 510(k)

Evolution Esophageal Stent System – Partially Covered

K-Number: K162717 · 2016-12-21

Decision Date2016-12-21
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Related Clinical Trials

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.

Other records listing Cook Ireland, Ltd. as applicant

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.

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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.

Official Source

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