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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 K253657
Device Name Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads
Applicant
Covidien (Part of Medtronic)
60 Middletown Ave.
North Haven,  CT  06473
Applicant Contact Fei Li
Correspondent
Covidien (Part of Medtronic)
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact Fei Li
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received11/20/2025
Decision Date 04/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Clinical Trials NCT05095935
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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