Tri-Staple 2.0 Reloads

Staple, Implantable

Covidien

The following data is part of a premarket notification filed by Covidien with the FDA for Tri-staple 2.0 Reloads.

Pre-market Notification Details

Device IDK202864
510k NumberK202864
Device Name:Tri-Staple 2.0 Reloads
ClassificationStaple, Implantable
Applicant Covidien 60 Middletown Avenue North Haven,  CT  06473
ContactCarolina Cabezas
CorrespondentCarolina Cabezas
Covidien 60 Middletown Avenue North Haven,  CT  06473
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-28
Decision Date2020-10-28

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