Signia Stapler (with New Software)

Staple, Implantable

Covidien

The following data is part of a premarket notification filed by Covidien with the FDA for Signia Stapler (with New Software).

Pre-market Notification Details

Device IDK201672
510k NumberK201672
Device Name:Signia Stapler (with New Software)
ClassificationStaple, Implantable
Applicant Covidien 60 Middletown Avenue North Haven,  CT  06473
ContactKatherine Y Choi
CorrespondentKatherine Y 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 Received2020-06-19
Decision Date2020-07-17

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