GIA Stapler With Tri-Staple Technology

Staple, Implantable

Covidien

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

Pre-market Notification Details

Device IDK221006
510k NumberK221006
Device Name:GIA Stapler With Tri-Staple Technology
ClassificationStaple, Implantable
Applicant Covidien Room 501, 502, 601, 602 No.3 Building No.2388, Chen Hang Road Min Hang District, Shanghai,  CN 201114
ContactYanjun Jiao
CorrespondentKatherine Choi
Covidien 60 Middletown Avenue North Haven,  CT  06473
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-05
Decision Date2022-04-29

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