# K132581: Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Cardica, Inc.
- Decided: Jan 7, 2014 after 144 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K842066 (1985). 58 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111825: Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM) Staplers, Covidien, Formerly US Surgical A Divison of Tyco H (2011) Summary page 3.
- K020779: Proximate and Endopath Linear Cutters and Staplers, Ethicon Endo-Surgery, Inc. (2002) Summary page 1.

## Most influential descendants
- K140118: Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue Cartridge (2014), 1 descendant of its own
- K140170: Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White Cartridge (2014), 1 descendant of its own
- K161137: Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload (2016), 0 descendants of its own

## Recalls of this device
- Nov 6, 2015 · Class II · Z-0482-2016: Cardica, Inc. has received reports that use of the Blue Cartridges with the MicroCutter XCHANGE 30 Stapler was associated with incomplete firing of staples, potentially resulting in an incomplete tran

## Indications for use
The MicroCutter XCHANGE h3O is intended for use in multiple open or minimally invasive surgical procedures for the transection, resection, and/or creation of anastornoses in small and large intestine as well as the transection of the appendix.

Source page: https://510kreport.com/device/K132581
Methodology: https://510kreport.com/methodology