Cleared Traditional

K251482 - AEON Endoscopic Powered Stapler

K251482 is an FDA 510(k) clearance for AEON Endoscopic Powered Stapler, manufactured by Lexington Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAG cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K251482 · Lexington Medical, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 2025
Decision
58d
Days
Class 2
Risk

K251482 is an FDA 510(k) clearance for the AEON™ Endoscopic Powered Stapler. Classified as Stapler, Surgical (product code GAG), Class II - Special Controls.

Submitted by Lexington Medical, Inc. (Bedford, US). The FDA issued a Cleared decision on July 11, 2025 after a review of 58 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4740 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lexington Medical, Inc. devices

FDA 510(k) Submission Details - K251482

510(k) Number K251482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAG Device Classification - Class 2, Special Controls

Product Code GAG Stapler, Surgical
Device Class Class 2 - 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.
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 - GAG Stapler, Surgical

All 32
Devices cleared under the same product code (GAG) and FDA review panel - the closest regulatory comparables to K251482.
Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT)
K253527 · Covidien, LLC · Jul 2026
da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
K243596 · Intuitive Surgical, Inc. · Mar 2025
Signia™ Circular Adapter (Standard Length) (SIGCIRSTND)
K240881 · Covidien (Part of Medtronic) · Nov 2024
ECHELON 3000 45mm Compact Stapler (ECH45C)
K241629 · Ethicon Endo-Surgery, LLC · Jul 2024
AEON Endoscopic Powered Stapler (Short/AEPH060)
K234039 · Lexington Medical, Inc. · May 2024
GIA™ Stapler with Tri-Staple™ Technology
K231934 · Covidien · Oct 2023