# K080972: Echelon Zebra Cartridges, Models, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Sugery, LLC
- Decided: Jul 3, 2008 after 90 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: 1 generation back to K051002 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051002: Endopath Endocutter 60 Endoscopic Linear Cutter, Ethicon Endo-Surgery, Inc. (2005) Summary page 1.
- K070887: Endopath Linear Cutters and Staplers and ECHELON60 Endoscopic Linear Cutters and Staplers (and Reloads), Ethicon Endo-Surgery, LLC (2007) Summary page 1.

## Indications for use
The Echelon Endoscopic Linear Cutters and Cartridges are intended for transaction, resection, and/or anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

Source page: https://510kreport.com/device/K080972
Methodology: https://510kreport.com/methodology