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AEON™ Endoscopic Powered Stapler

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251482

by Lexington Medical, Inc.

Identifiers

510(k) Number
K251482 FDA 510(k)
FDA Product Code
GAG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4740 FDA 510(k)
Regulation Number
878.4740 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

AEON™ Endoscopic Powered Stapler by Lexington Medical, Inc. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Sources (1)

  • FDA 510(k) K251482 24 fields · synced Jun 18, 2026