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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 K253527
Device Name Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)
Applicant
Covidien, LLC
60 Middletown Ave.
North Haven,  CT  06473
Applicant Contact Frank Maistrovich
Correspondent
Covidien, LLC
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact Frank Maistrovich
Regulation Number878.4740
Classification Product Code
GAG  
Subsequent Product Code
GDW  
Date Received11/13/2025
Decision Date 07/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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