Cleared Traditional

AEON? Endoscopic Powered Stapler

K251482 · Lexington Medical, Inc. · General & Plastic Surgery
Jul 2025
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K251482 is an FDA 510(k) clearance for the AEON? Endoscopic Powered Stapler, a Stapler, Surgical (Class II — Special Controls, product code GAG), submitted by Lexington Medical, Inc. (Bedford, US). The FDA issued a Cleared decision on July 11, 2025, 58 days after receiving the submission on May 14, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4740.

Submission Details

510(k) Number K251482 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2025
Decision Date July 11, 2025
Days to Decision 58 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.

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