# K970720: Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO Knife Endoscopic Linear Stapler

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Jun 27, 1997 after 120 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
94 later devices descend from it; 3 cite it directly.
1 of 95 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K980815: Endopath EZ45 Endoscopic Linear Cutter (1998), 92 descendants of its own
- K980023: Endopath and Proximate Linear Cutters (1998), 88 descendants of its own
- K020779: Proximate and Endopath Linear Cutters and Staplers (2002), 87 descendants of its own
- K020719: Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with Blue and Green Reload Cartridges (2002), 47 descendants of its own
- K030653: Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital Loading Units with Reloads (2003), 46 descendants of its own

## Indications for use
The ENDOPATH® EZ45 Endoscopic Linear Cutter [and the ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler] has application in multiple open and other minimally invasive surgical procedures for transection, resection, [and/or creation of anastomoses] and can be used with staple line or tissue buttressing materials, such as bovine pericardium.

Source page: https://510kreport.com/device/K970720
Methodology: https://510kreport.com/methodology