The FDA 510(k) clearance was obtained for the integrated system combining the extraction device with blood and bone marrow kits, acknowledging SMART M-CELL is designed to isolate and concentrate CD34+ cell-rich blood fractions and growth factors derived from patients’ own blood and bone marrow.
K250516 SMART M-CELL PRP Concentration System FDA Clearance
K250518 SMART M-CELL Bone Marrow Concentration System FDA Clearance