Cleared Traditional

AEON Endoscopic Stapler (K222210) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222210 · Lexington Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
270d
Days
Class 2
Risk

K222210 is an FDA 510(k) clearance for the AEON Endoscopic Stapler. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Lexington Medical, Inc. (Bedford, US). The FDA issued a Cleared decision on April 21, 2023 after a review of 270 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Lexington Medical, Inc. devices

Submission Details

510(k) Number K222210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 115d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GDW Staple, Implantable

All 128
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K222210.
ECHELON 4000 60mm Compact Stapler (EC3D60C)
K241630 · Ethicon Endo-Surgery, LLC · Oct 2024
Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series)
K242679 · Fengh Medical Co., Ltd. · Oct 2024
Anika Tissue Tack Fixation System
K222487 · Anika Therapeutics, Inc. · May 2023
ECHELON LINEAR™ 60 mm Cutter (GLC60)
K223760 · Ethicon Endo-Surgery · Mar 2023
Disposable Endoscopic Cutter Stapler and Cartridge
K211197 · Changzhou Waston Medical Appliance Co., Ltd. · Jan 2023
EEA Circular Stapler with Tri-Staple Technology
K221771 · Covidien · Nov 2022