Reapplix announces new US FDA 510(k) clearance for expanded system, including automated centrifuge, a further advancement of its regenerative wound care technology
Reapplix today announced that it has received US FDA 510(k) clearance for its 3C Patch System® including the 3C Patch Centrifuge.
This new 510(k) clearance expands the 3C Patch System® to include Reapplix’s new 3C Patch Centrifuge, which features optical sensors and automates the process of producing a 3C Patch®. This further improves usability as health care professionals now need just a few minutes’ hands on time to prepare the 3C Patch.
The proprietary 3C Patch Centrifuge further enhances the simple-to-use 3C Patch® device technology and has been cleared for the following indications for use: “The 3C Patch System® is intended to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the PRP gel produced by the 3C Patch System® is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and mechanically or surgically-debrided wounds.”Reapplix Press release - 510(k) for expanded System April 2017