# K161137: Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload

- Pathway: 510(k) (Traditional)
- Applicant: Cardica, Inc.
- Decided: Jul 20, 2016 after 89 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K842066 (1985). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132581: Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple Cartridge, Cardica, Inc. (2014) Summary page 4.
- K140118: Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue Cartridge, Cardica, Inc. (2014) Summary page 4.
- K140170: Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White Cartridge, Cardica, Inc. (2014) Summary page 4.
- K151081: MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge, Cardica, Inc. (2016) Summary page 4.

## Indications for use
The MicroCutter 5/80 is intended for transection and resection in multiple open or minimally invasive urologic, thoracic, and pediatric surgical procedures, as well as application for transection, resection, and/or creation of anastomoses in the small and large intestine, and the transection of the appendix.

Source page: https://510kreport.com/device/K161137
Methodology: https://510kreport.com/methodology