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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K251229
Device Name EndoFix™Tissue Fixation System
Applicant
Softac Medical Technologies
111 Washington St.
Suite 204
Plainville,  MA  02762
Applicant Contact Rickey Hart
Correspondent
Softac Medical Technologies
111 Washington St.
Suite 204
Plainville,  MA  02762
Correspondent Contact Rickey Hart
Regulation Number876.5010
Classification Product Code
FGE  
Subsequent Product Codes
OCW   PKL  
Date Received04/21/2025
Decision Date 08/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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