EEA Circular Stapler With Tri-Staple Technology

Staple, Implantable

Covidien

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 IDK221771
510k NumberK221771
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
ContactLeo Chan
CorrespondentLeo Chen
Covidien Rooms 501, 502, 601, 602, No.3 Building No.2388 Chen Hang Road Shanghai,  CN
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-21
Decision Date2022-11-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521593098 K221771 000
20884521593081 K221771 000
20884521592992 K221771 000
20884521592985 K221771 000

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