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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name platelet and plasma separator for bone graft handling
510(k) Number BK251157
Tradename ENDORET Kit
Device Name Platelet And Plasma Separator For Bone Graft Handling
Original Applicant
B.T.I Biotechnology Institute, S.L.
leonardo davinci 14
parque tecnologico de alava
minano,  Alava,  01510, 
Regulation Number864.9245
Classification Product Code
ORG  
Date Received01/07/2025
Decision Date 10/03/2025
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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