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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 K253852
Device Name MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
Applicant
Ethicon, Inc.
1000 Us-202
Raritan,  NJ  08869
Applicant Contact Anju Malhotra
Correspondent
Ethicon, Inc.
1000 Us-202
Raritan,  NJ  08869
Correspondent Contact Anju Malhotra
Regulation Number878.4493
Classification Product Code
GAM  
Date Received12/02/2025
Decision Date 02/06/2026
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 Yes
Predetermined Change
Control Plan Authorized		 No
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