510(k) K132581

MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE by Cardica, Inc. — Product Code GDW

K132581 is an FDA 510(k) premarket notification submitted by Cardica, Inc. for the device "MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE". The FDA issued a decision of Substantially Equivalent on January 7, 2014. 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.