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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 K202507
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 Chen
Correspondent
Covidien
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact Katherine Y Choi
Regulation Number878.4750
Classification Product Code
GDW  
Date Received08/31/2020
Decision Date 01/21/2021
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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