EEA Circular Stapler With Tri-Staple Technology

Staple, Implantable


The following data is part of a premarket notification filed by Covidien with the FDA for Eea Circular Stapler With Tri-staple Technology.

Pre-market Notification Details

Device IDK221005
510k NumberK221005
Device Name:EEA Circular Stapler With Tri-Staple Technology
ClassificationStaple, Implantable
Applicant Covidien Rooms 501, 502, 601, 602, No.3 Building No.2388 Chen Hang Road, Min Hang District Shanghai,  CN 201114
ContactLeo Chen
CorrespondentKatherine Choi
Covidien 60 Middletown Avenue North Haven,  CT  06473
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-05
Decision Date2022-04-29

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