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510(k) K251229

EndoFix™Tissue Fixation System by Softac Medical Technologies — Product Code FGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2025
Date Received
April 21, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stents, Drains And Dilators For The Biliary Ducts
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

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