Medical Device Manufacturer · US , Billerica , MA

Lexington Medical, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2017

Recent clearances: AEON™ Endoscopic Powered Stapler, AEON Endoscopic Powered Stapler (Short/AEPH060), AEON Endoscopic Stapler

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Lexington Medical, Inc. General & Plastic Surgery ✕

9 devices

1-9 of 9

Cleared Jul 11, 2025

AEON™ Endoscopic Powered Stapler

General & Plastic Surgery · 58d

Cleared May 07, 2024

AEON Endoscopic Powered Stapler (Short/AEPH060)

General & Plastic Surgery · 138d

Cleared Apr 21, 2023

AEON Endoscopic Stapler

General & Plastic Surgery · 270d

Cleared Oct 09, 2020

AEON Endoscopic Stapler

General & Plastic Surgery · 93d

Cleared Oct 11, 2019

AEON Laparoscopic Instruments

General & Plastic Surgery · 53d

Cleared Nov 28, 2018

AEON Endoscopic Stapler

General & Plastic Surgery · 89d

Cleared Mar 27, 2018

AEON Retrieval Bag

General & Plastic Surgery · 70d

Cleared Feb 01, 2018

AEON Endoscopic Stapler

General & Plastic Surgery · 87d

Cleared Nov 17, 2017

AEON Endoscopic Stapler

General & Plastic Surgery · 170d