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AEON Endoscopic Stapler

FDA 510(k)

Class II (US FDA 510(k))

510(k) K171589

by Lexington Medical, Inc.

Identifiers

510(k) Number
K171589 FDA 510(k)
FDA Product Code
GDW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4750 FDA 510(k)
Regulation Number
878.4750 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

An endoscopic stapler is a device used to cut and staple tissue during endoscopic surgical procedures. The AEON Endoscopic Stapler is a manual or powered surgical stapling system designed for precision cutting and stapling in endoscopic surgery.

It is supplied by Lexington Medical, Inc. and has received FDA 510(k) clearance (K171589) as substantially equivalent to a predicate device. The device is classified as Class II under regulation number 878.4750 and is intended for use in general and plastic surgery settings.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AEON Manual Surgical Stapler | Multi-Speed Gear, AEON Powered Surgical Stapler | Signia & Echelon Alternative, AEON Endoscopic Stapler - healthcareequipment.org, AEON Endoscopic Stapler - healthcareequipment.org

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Lexington Medical, Inc.

Sources (1)

  • FDA 510(k) K171589 24 fields · synced Sep 19, 2026