# K222210: AEON Endoscopic Stapler

- Pathway: 510(k) (Traditional)
- Applicant: Lexington Medical, Inc.
- Decided: Apr 21, 2023 after 270 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: 11 generations back to K940967 (1994). 29 ancestors in all.
2 later devices descend from it; 2 cite it directly.
6 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201882: AEON Endoscopic Stapler, Lexington Medical, Inc. (2020) Summary page 4.

## Most influential descendants
- K251482: AEON™ Endoscopic Powered Stapler (2025), 0 descendants of its own
- K234039: AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) (2024), 0 descendants of its own

## Indications for use
The AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses. The instrument may also be used for transection and resection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney, and spleen.

Source page: https://510kreport.com/device/K222210
Methodology: https://510kreport.com/methodology