Cardica submits 510(k) application for surgical system

08/19/2013 | MassDevice.com (Boston)

Cardica has submitted to the FDA its 510(k) clearance application for the MicroCutter Xchange 30, a surgical stapler and cutting system used to minimize postoperative pain and other complications after a laparoscopic procedure. The FDA submission is backed by a European study indicating that only one in 160 patients who had surgery using the MicroCutter experienced an adverse event tied to the device.

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