Redwood City, Calif.-based Cardica (NSDQ:CRDC) said it filed for 510(k) clearance from the FDA for its surgical device.
Cardica said it filed all paperwork for a 510(k) for its MicrroCutter Xchange 30, which is already on the shelves in Europe. The U.S. is the largest market for surgical staplers world wide, according to the company.
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The FDA will review supporting evidence for the MicroCutter based on a recently completed European trial, which only reported 1 device-related adverse events out of 160 patients who went under the knife with MicroCutter.
MicroCutter is designed to reduce complications and post-operative pain from laparoscopic surgery. It has a much smaller cross-sectional area than typical surgical staplers, and can articulate 80 degrees, according to Cardica.
The company promised to submit the U.S. application after submitting a cartridge design validation application to Japan’s Pharmaceuticals & Medical Devices Agency August 13.