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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 K243897
Device Name PDS™ Plus Antibacterial (Polydioxanone) 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 Number878.4840
Classification Product Code
NEW  
Date Received12/19/2024
Decision Date 11/12/2025
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 Yes
Predetermined Change
Control Plan Authorized		 No
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