# K141952: Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon Vascular White Reloads for Advanced

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Nov 24, 2014 after 129 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K821994 (1982). 24 ancestors in all.
4 later devices descend from it; 3 cite it directly.
2 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110385: Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear Cutter, Ethicon Endo-Surgery, Inc. (2011) Summary page 4.
- K081146: Echelon Endoscopic Linear Cutters (Articulating and Straight), Ethicon Endo-Surgery, LLC (2008) Summary page 4.
- K111111: Endopath Ets 35MM Endoscopic Linear Cutter and Reloads, and Ets-Flex 35MM Endoscopic Articulating Linear Cutter and Relo, Ethicon Endo-Surgery, LLC (2011) Summary page 4.
- K070887: Endopath Linear Cutters and Staplers and ECHELON60 Endoscopic Linear Cutters and Staplers (and Reloads), Ethicon Endo-Surgery, LLC (2007) Summary page 4.
- K020779: Proximate and Endopath Linear Cutters and Staplers, Ethicon Endo-Surgery, Inc. (2002) Summary page 4.
- K121600: Echelon 60 Endoscpic Linear Cutter Reload, White, Ethicon Endo-Surgery, LLC (2012) Summary page 4.

## Most influential descendants
- 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
- Apr 22, 2025 · Class I · Z-1746-2025: Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not 
- Feb 26, 2015 · Class II · Z-1641-2015: During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line.

## Indications for use
The Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip and its reloads are intended for transection and resection of tissue and vasculature. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures.

Source page: https://510kreport.com/device/K141952
Methodology: https://510kreport.com/methodology