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 IDK192330
510k NumberK192330
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
ContactSarah Tang
CorrespondentFrank Gianelli
Covidien 60 Middletown Avenue North Haven,  CT  06473
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-27
Decision Date2020-01-23

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