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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 K240881
Device Name Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)
Applicant
Covidien (Part of Medtronic)
60 Middletown Ave.
North Haven,  CT  06473
Applicant Contact Carolina Cabezas
Correspondent
Covidien (Part of Medtronic)
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact Carolina Cabezas
Regulation Number878.4740
Classification Product Code
GAG  
Subsequent Product Code
GDW  
Date Received04/01/2024
Decision Date 11/01/2024
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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