# K111111: Endopath Ets 35MM Endoscopic Linear Cutter and Reloads, and Ets-Flex 35MM Endoscopic Articulating Linear Cutter and Relo

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Jun 8, 2011 after 49 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K821994 (1982). 18 ancestors in all.
5 later devices descend from it; 1 cites it directly.
1 of 24 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961390: Endopath Ets Linear/Ets-Flex Articulating Linear Endoscopic Cutter, Ethicon Endo-Surgery, Inc. (1996) Summary page 1.
- K020779: Proximate and Endopath Linear Cutters and Staplers, Ethicon Endo-Surgery, Inc. (2002) 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.

## Most influential descendants
- K141952: Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon Vascular White Reloads for Advanced (2014), 4 descendants of its own
- K191070: Signia Small Diameter Reloads (2019), 2 descendants of its own
- K222641: Signia™ Small Diameter Reloads Including Regular (Round) Tip Version (2022), 1 descendant of its own
- K254291: easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges (2026), 0 descendants of its own
- K253657: Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads (2026), 0 descendants of its own

## Recalls of this device
- Mar 31, 2017 · Class II · Z-2174-2017: There is a risk that the pinion gear in the device could fail under extreme use cases.
- Jul 15, 2016 · Class II · Z-0295-2017: Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device c
- Jul 15, 2016 · Class II · Z-0296-2017: Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device c

## Indications for use
ENDOPATH ETS 35mm Endoscopic Linear Cutter and Reloads, and ETS-Flex 35mm Endoscopic Articulating Linear Cutter and Reloads have application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses. 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/K111111
Methodology: https://510kreport.com/methodology