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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 K252047
Device Name STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices
Applicant
ETHICON, Inc.
1000 Rte. 202 S.
Raritan,  NJ  08869
Applicant Contact Samantha Mecker
Correspondent
ETHICON, Inc.
1000 Rte. 202 S.
Raritan,  NJ  08869
Correspondent Contact Samantha Mecker
Regulation Number878.4840
Classification Product Code
NEW  
Date Received06/30/2025
Decision Date 05/18/2026
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 Yes
Predetermined Change
Control Plan Authorized		 No
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