GIA Auto Suture Stapler With DST Series Technology

Staple, Implantable

Covidien

The following data is part of a premarket notification filed by Covidien with the FDA for Gia Auto Suture Stapler With Dst Series Technology.

Pre-market Notification Details

Device IDK221013
510k NumberK221013
Device Name:GIA Auto Suture Stapler With DST Series Technology
ClassificationStaple, Implantable
Applicant Covidien 60 Middletown Avenue North Haven,  CT  06473
ContactRobert Zott
CorrespondentAngela Van Arsdale
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 Date2022-05-05

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