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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, Orthopaedics, Reinforcement Of Tendon
510(k) Number K262343
Device Name Dynavisc
Applicant
Fziomed, Inc.
231 Bonetti Dr.
San Luis Obispo,  CA  93401
Applicant Contact Paul Mraz
Correspondent
Fziomed, Inc.
231 Bonetti Dr.
San Luis Obispo,  CA  93401
Correspondent Contact Lisa Gawehn
Regulation Number878.3300
Classification Product Code
OWW  
Date Received07/10/2026
Decision Date 10/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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