Cleared Traditional

AEON Endoscopic Stapler

K222210 · Lexington Medical, Inc. · General & Plastic Surgery
Apr 2023
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K222210 is an FDA 510(k) clearance for the AEON Endoscopic Stapler, a Staple, Implantable (Class II — Special Controls, product code GDW), submitted by Lexington Medical, Inc. (Bedford, US). The FDA issued a Cleared decision on April 21, 2023, 270 days after receiving the submission on July 25, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.

Submission Details

510(k) Number K222210 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2022
Decision Date April 21, 2023
Days to Decision 270 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GDW — Staple, Implantable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4750

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