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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Absorbable, Abdominal Hernia
510(k) Number K262443
Device Name Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030)
Applicant
Sofradim Production
116 Ave. Du Formans
Trévoux,  FR 01600
Applicant Contact Jhony Mallet
Correspondent
Sofradim Production
116 Ave. Du Formans
Trévoux,  FR 01600
Correspondent Contact Ng Wing
Regulation Number878.3300
Classification Product Code
OWT  
Subsequent Product Codes
FTL   OOD  
Date Received07/16/2026
Decision Date 10/16/2026
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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