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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polypropylene
510(k) Number K253572
Device Name STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device
Applicant
ETHICON, Inc.
1000 Us-202
Raritan,  NJ  08869
Applicant Contact Jenny Wang
Correspondent
ETHICON, Inc.
1000 Us-202
Raritan,  NJ  08869
Correspondent Contact Jenny Wang
Regulation Number878.5010
Classification Product Code
GAW  
Date Received11/17/2025
Decision Date 03/27/2026
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 No
Predetermined Change
Control Plan Authorized		 No
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