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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K253530
Device Name Trexon™ Monofilament Synthetic Absorbable Suture
Applicant
Medtronic
60 Middletown Ave.
North Haven,  CT  06473
Applicant Contact Nicole Boroumand
Correspondent
Covidien, LLC
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact Frank Maistrovich
Regulation Number878.4493
Classification Product Code
GAM  
Date Received11/13/2025
Decision Date 05/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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