# K151081: MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Cardica, Inc.
- Decided: Jan 15, 2016 after 268 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: 3 generations back to K821994 (1982). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020779: Proximate and Endopath Linear Cutters and Staplers, Ethicon Endo-Surgery, Inc. (2002) Summary page 4.
- K002398: Endopath ETS45, Ets FLEX45, Ets Compact-FLEX45 Linear Cutters, Ets FLEX45 and Ets Compact-FLEX45 NO-Knife Articulating, Ethicon Endo-Surgery, Inc. (2000) Summary page 4.

## Most influential descendants
- K161137: Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload (2016), 0 descendants of its own

## Indications for use
The MicroCutter XCHANGE® 30 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/K151081
Methodology: https://510kreport.com/methodology