510(k) K151081

MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge by Cardica, Inc. — Product Code GDW

K151081 is an FDA 510(k) premarket notification submitted by Cardica, Inc. for the device "MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge". The FDA issued a decision of Substantially Equivalent on January 15, 2016. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Cardica, Inc. has at least 10 other 510(k) clearances on record.