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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 K212810
Device Name MONOFIX PGCL, knotless wound closure device
Applicant
Samyang Holdings Corp., Ltd.
55, Munpyeongseo-Ro, 18beon-Gil
Daedeok-Gu,  KR 34302
Applicant Contact Ahram Kim
Correspondent
Wise Company, Inc.
#507, #508, 166 Gasan Digital 2-Ro
Geumcheon-Gu,  KR 08503
Correspondent Contact Sanglok Lee
Regulation Number878.4493
Classification Product Code
GAM  
Date Received09/03/2021
Decision Date 08/05/2022
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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