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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stapler, Surgical
510(k) Number K221629
Device Name Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)
Applicant
Covidien
60 Middletown Ave.
North Haven,  CT  06473
Applicant Contact Katherine Y. Choi
Correspondent
Covidien
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact Katherine Y. Choi
Regulation Number878.4740
Classification Product Code
GAG  
Subsequent Product Code
GDW  
Date Received06/06/2022
Decision Date 02/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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