# K002398: Endopath ETS45, Ets FLEX45, Ets Compact-FLEX45 Linear Cutters, Ets FLEX45 and Ets Compact-FLEX45 NO-Knife Articulating

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Nov 3, 2000 after 88 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.
92 later devices descend from it; 6 cite it directly.
1 of 93 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 its predicate without a number.
- (no number) ENDOPATH® ETS45 Linear Cutters, Linear Staplers and Reloads: named in the summary without a submission number

## Most influential descendants
- K020779: Proximate and Endopath Linear Cutters and Staplers (2002), 87 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
- K071708: I45, I45S, I60, and I60S (2007), 21 descendants of its own

## Indications for use
The ENDOPATH® ETS45 Endoscopic Linear Cutters, the ETS-Flex45 Endoscopic Articulating Linear Cutters, and the ETS Compact- Flex45 Articulating Linear Cutter are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing material such as bovine pericardium. The ENDOPATH® ETS Flex45 No-Knife Articulating Linear Staplers and ETS Compact-Flex45 No-Knife Articulating Linear Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic, and pediatric procedures. They can be used with staple line or tissue buttressing material such as bovine pericardium.

Source page: https://510kreport.com/device/K002398
Methodology: https://510kreport.com/methodology