510(k) K140118

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

K140118 is an FDA 510(k) premarket notification submitted by Cardica, Inc. for the device "MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE". The FDA issued a decision of Substantially Equivalent on February 25, 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2014
Date Received
January 16, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
Submission Type