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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 K221771
Device Name EEA Circular Stapler with Tri-Staple Technology
Applicant
Covidien
Rooms 501, 502, 601, 602, No. 3 building
No. 2388 Chen Hang Road
Min Hang District, Shanghai,  CN 201114
Applicant Contact Leo Chan
Correspondent
Covidien
Rooms 501, 502, 601, 602, No.3 building
No.2388 Chen Hang Road
Shanghai,  CN
Correspondent Contact Leo Chen
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received06/21/2022
Decision Date 11/30/2022
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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