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

Stent, Metallic, Expandable, Duodenal

Cook Ireland Ltd.

The following data is part of a premarket notification filed by Cook Ireland Ltd. with the FDA for Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered.

Pre-market Notification Details

Device IDK163468
510k NumberK163468
Device Name:Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered
ClassificationStent, Metallic, Expandable, Duodenal
Applicant Cook Ireland Ltd. O'Halloran Road, National Technology Park Limerick,  IE
ContactJacinta Kilmartin
CorrespondentJacinta Kilmartin
Cook Ireland Ltd. O'Halloran Road, National Technology Park Limerick,  IE
Product CodeMUM  
CFR Regulation Number878.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-12
Decision Date2017-05-04
Summary:summary

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