Cleared Traditional

AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)

K234039 · Lexington Medical, Inc. · General & Plastic Surgery

May 2024

Decision

138d

Days

Class 2

Risk

About This 510(k) Submission

K234039 is an FDA 510(k) clearance for the AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260), a Stapler, Surgical (Class II — Special Controls, product code GAG), submitted by Lexington Medical, Inc. (Bedford, US). The FDA issued a Cleared decision on May 7, 2024, 138 days after receiving the submission on December 21, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4740.

Submission Details

510(k) Number	K234039 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2023
Decision Date	May 07, 2024
Days to Decision	138 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GAG — Stapler, Surgical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4740
Definition	A Surgical Stapler For Internal Use Is A Specialized Prescription Device Used To Deliver Compatible Staples To Internal Tissues During Surgery For Resection, Transection, And Creating Anastomoses.