# K980815: Endopath EZ45 Endoscopic Linear Cutter

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: May 1, 1998 after 59 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
Longest line of descent: 1 generation back to K970720 (1997). 1 ancestor in all.
92 later devices descend from it; 3 cite it directly.
1 of 94 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970720: Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO Knife Endoscopic Linear Stapler, Ethicon Endo-Surgery, Inc. (1997) Summary page 1.

## Most influential descendants
- 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
- K040398: Surgassist Straight Linear 4 Row NO Knife Dlus with Reloads (2004), 45 descendants of its own
- K040720: Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MM (2004), 25 descendants of its own

## Indications for use
The ENDOPATH®EZ45 Endoscopic Linear Cutter is intended for transection, resection, and /or creation of anastomoses, has application in multiple:open or minimally invasive surgical procedures, including radical prostatectomy, and can be used with staple line or tissue buttressing materials, such as bovine pericardium.

Source page: https://510kreport.com/device/K980815
Methodology: https://510kreport.com/methodology