FDA 510(k)

Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered

K-Number: K163468 · 2017-05-04

Decision Date2017-05-04

Product CodeMUM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered is a medical device manufactured by Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2017-05-04 under approval number K163468. The device is classified under product code MUM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered?

Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered is a medical device that received FDA 510(k) clearance on 2017-05-04. It is manufactured by Cook Ireland, Ltd.. The 510(k) number is K163468.

When was Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered approved by the FDA?

Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered received FDA 510(k) clearance on 2017-05-04, under approval number K163468.

What company makes Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered?

Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered is manufactured by Cook Ireland, Ltd..

What is the FDA product code for Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered?

The FDA product code for Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered is MUM.

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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) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 25262248 Unique device identifiers for coronary stent postmarket surveillance and research: a report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier demonstration. American heart journal (2014)

Other Devices by Cook Ireland, Ltd.

K163018Zilver 635 Biliary Stent K162717Evolution Esophageal Stent System Partially Covered 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 K163169Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent

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Related Devices (Code: MUM)

K223067Niti-S Duodenal Stent; Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd. K250663Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentTaewoong Medical 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.