# K182380: AEON Endoscopic Stapler

- Pathway: 510(k) (Traditional)
- Applicant: Lexington Medical, Inc.
- Decided: Nov 28, 2018 after 89 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: 9 generations back to K940967 (1994). 27 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K173443: AEON Endoscopic Stapler, Lexington Medical, Inc. (2018) Summary page 4.

## Most influential descendants
- K201882: AEON Endoscopic Stapler (2020), 3 descendants of its own
- K222210: AEON Endoscopic Stapler (2023), 2 descendants of its own
- 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.

Source page: https://510kreport.com/device/K182380
Methodology: https://510kreport.com/methodology