# K150026: Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: May 18, 2015 after 131 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). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070887: Endopath Linear Cutters and Staplers and ECHELON60 Endoscopic Linear Cutters and Staplers (and Reloads), Ethicon Endo-Surgery, LLC (2007) Summary page 4.
- K061156: Endopath Endocutter 60 Endoscopic Linear Cutter, Models EC60, SC60 and LONG60 and Endopath & Proximate Linear Cutters, Ethicon Endo-Surgery, Inc. (2006) Summary page 4.
- K020779: Proximate and Endopath Linear Cutters and Staplers, Ethicon Endo-Surgery, Inc. (2002). Our reading of the summary gave K020079, FDA’s number for Bladeworks Microkeratome Blade, Model 7061 (Blade Works, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter and…”.
- 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.
- K961390: Endopath Ets Linear/Ets-Flex Articulating Linear Endoscopic Cutter, Ethicon Endo-Surgery, Inc. (1996) Summary page 4.

## Indications for use
The Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, ETS-Flex45 No-Knife Articulating Linear Stapler and reloads are intended for transection, resection, and/or creation of 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 buttressing material. The instrument 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/K150026
Methodology: https://510kreport.com/methodology