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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
Rm.S 501,502,601,602, #3 Bldg., #2388 Chen Hang Rd.
Min Hang District, Shanghai,  CN 201114
Applicant Contact Leo Chan
Correspondent
Covidien
Rm.S 501, 502, 601, 602, #3 Bldg.
#2388 Chen Hang Rd.
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
Predetermined Change
Control Plan Authorized		 No
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