# K251482: AEON™ Endoscopic Powered Stapler

- Pathway: 510(k) (Traditional)
- Applicant: Lexington Medical, Inc.
- Decided: Jul 11, 2025 after 58 days
- Product code: GAG (Stapler, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K940967 (1994). 30 ancestors in all.
No later device cites it as a predicate yet.
6 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222210: AEON Endoscopic Stapler, Lexington Medical, Inc. (2023) Summary page 5.

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

Source page: https://510kreport.com/device/K251482
Methodology: https://510kreport.com/methodology