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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Surgical, Absorbable, Polydioxanone
510(k) Number K253879
Device Name MONOFIX PDO
Applicant
Samyang Holdings Corporation
55, Munpyeongseo-Ro 18beon-Gil
Daedeok-Gu,  KR 34302
Applicant Contact Kim Ahram
Correspondent
RQM+
5000 Centregreen Way, Suite 100
Cary,  NC  27513
Correspondent Contact Samy Puccio
Regulation Number878.4840
Classification Product Code
NEW  
Date Received12/04/2025
Decision Date 08/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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