# Lexington Medical, Inc.

- Location (FDA's records): Billerica, MA
- FDA decisions: 9 (2017–2025): 9 510(k) clearances
- Product codes: GDW (5), GAG (2), GCJ (1), GEI (1)
- 510(k) review time since 2016: median 91 days, against 92 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 9 (5 its own); citations of its devices by later devices: 5 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Touchstone International Medical Science Co., Ltd.: 2 (https://510kreport.com/company/touchstone-international-medical-science)
- Espiner Medical Limited: 1 (https://510kreport.com/company/espiner-medical)
- Unimax Medical Systems, Inc.: 1 (https://510kreport.com/company/unimax-medical-systems)

## Its most-cited devices
- K222210: AEON Endoscopic Stapler (2023), cited by 2
- K182380: AEON Endoscopic Stapler (2018), cited by 1
- K201882: AEON Endoscopic Stapler (2020), cited by 1
- K173443: AEON Endoscopic Stapler (2018), cited by 1

## Recent decisions
- K251482: AEON™ Endoscopic Powered Stapler (Jul 11, 2025)
- K234039: AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) (May 7, 2024)
- K222210: AEON Endoscopic Stapler (Apr 21, 2023)
- K201882: AEON Endoscopic Stapler (Oct 9, 2020)
- K192235: AEON Laparoscopic Instruments (Oct 11, 2019)
- K182380: AEON Endoscopic Stapler (Nov 28, 2018)
- K180114: AEON Retrieval Bag (Mar 27, 2018)
- K173443: AEON Endoscopic Stapler (Feb 1, 2018)

Source page: https://510kreport.com/company/lexington-medical