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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Implantable
510(k) Number K192720
Device Name GIA Stapler with Tri-Staple Technology
Applicant
Covidien
Rooms 501,502,601,602, No.3 building No.2388, Chen Hang Road
Min Hang District,  CN 201114
Applicant Contact Sarah Tang
Correspondent
Covidien
60 Middletown Avenue
North Haven,  CT  06473
Correspondent Contact Frank Gianelli
Regulation Number878.4750
Classification Product Code
GDW  
Date Received09/27/2019
Decision Date 03/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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