www.fdanews.com/articles/196018-emcyte-nabs-510k-clearance-for-platelet-rich-plasma-concentration-device
EmCyte Nabs 510(k) Clearance for Platelet Rich Plasma Concentration Device
February 26, 2020
The FDA granted EmCyte 510(k) clearance for its PurePRP (platelet rich plasma) Supraphysiologic concentrating system that prepares concentrations of PRP.
The device is now cleared for rapidly preparing autologous clinical PRP from small blood samples. PRP stimulates the growth necessary to repair damaged tissue.
PurePRP’s cell composition is “friendly to the local tissue environment making it an effective and well tolerated treatment application for patients,” the company said.