# K171589: AEON Endoscopic Stapler

- Pathway: 510(k) (Traditional)
- Applicant: Lexington Medical, Inc.
- Decided: Nov 17, 2017 after 170 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: 8 generations back to K940967 (1994). 26 ancestors in all.
No later device cites it as a predicate yet.
6 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141367: LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and Reloads, LC Series Linear Cutter and Reloads, Touchstone International Medical Science Co., Ltd. (2014) Summary page 4.

## Indications for use
The AEON Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses.

Source page: https://510kreport.com/device/K171589
Methodology: https://510kreport.com/methodology