Food & Drug Administration Clearances
Indication for Use - 510(k) Number: BK050055
Device Name: GenesisCS Component Concentrating Systems
Indication for Use: The GenesisCS Component Concentrating System is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of blood at the patient's point of care. The PRP can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements.
Indication for Use - 510(k) Number: K070666
Device Name: GenesisCS Component Concentrating Systems
Indication for Use: The GenesisCS Component Concentrating Systems is intended to be used in a clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood and for a preparation of a cell concentrate from bone marrow. The safety and effectiveness of this device for in vivo indications for use has not been established.
Indication for Use - 510(k) Number: K024080
Device Name: Secquire Cell Separator
Indication for Use: The Secquire cell separator is designed for the safe and effective preparation of low volume platelet rich plasma, and platelet poor plasma at the point of care
Patents
United States Patent - Patent No.: US 6,835,353 B2
Date of Patent: Dec. 28, 2004
Name of Patent: Centrifuge Tube Assembly
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