Medical Device Manufacturer · US , Billerica , MA

Lexington Medical, Inc.

9 submissions · 9 cleared · Since 2017
9
Total
9
Cleared
0
Denied

Lexington Medical, Inc. — FDA 510(k) Submissions

Lexington Medical, Inc. has submitted 9 FDA 510(k) premarket notifications since 2017, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Staple, Implantable, Stapler, Surgical, Laparoscope, General & Plastic Surgery, Electrosurgical, Cutting & Coagulation & Accessories . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
AEON? Endoscopic Powered Stapler
K251482 · GAG Stapler, Surgical · General & Plastic Surgery
Jul 2025 58d
AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)
K234039 · GAG Stapler, Surgical · General & Plastic Surgery
May 2024 138d
AEON Endoscopic Stapler
K222210 · GDW Staple, Implantable · General & Plastic Surgery
Apr 2023 270d
AEON Endoscopic Stapler
K201882 · GDW Staple, Implantable · General & Plastic Surgery
Oct 2020 93d
AEON Laparoscopic Instruments
K192235 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Oct 2019 53d
AEON Endoscopic Stapler
K182380 · GDW Staple, Implantable · General & Plastic Surgery
Nov 2018 89d
AEON Retrieval Bag
K180114 · GCJ Laparoscope, General &... · General & Plastic Surgery
Mar 2018 70d
AEON Endoscopic Stapler
K173443 · GDW Staple, Implantable · General & Plastic Surgery
Feb 2018 87d
AEON Endoscopic Stapler
K171589 · GDW Staple, Implantable · General & Plastic Surgery
Nov 2017 170d
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