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Echelon Endoscopic Linear Cutter Reload, Black

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131663

by Ethicon Endo-Surgery, LLC

Identifiers

510(k) Number
K131663 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)

The Echelon Endoscopic Linear Cutter Reload, Black is a medical device used for cutting. It is classified as a staple, implantable device.

The device is supplied by Ethicon Endo-Surgery, LLC and has been cleared with FDA 510K authorization. It is used in general and plastic surgery settings.

Frequently asked questions

What is the Echelon Endoscopic Linear Cutter Reload used for?

The Echelon Endoscopic Linear Cutter Reload is used for cutting in general and plastic surgery settings.

Is the Echelon Endoscopic Linear Cutter Reload sterile?

The device data does not specify the sterility of the Echelon Endoscopic Linear Cutter Reload, it is recommended to consult the manufacturer's instructions.

What is the regulatory status of the Echelon Endoscopic Linear Cutter Reload?

The Echelon Endoscopic Linear Cutter Reload has been cleared with FDA 510K authorization, indicating it is substantially equivalent to a predicate device.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ethicon Endo-Surgery, LLC

Sources (1)

  • FDA 510(k) K131663 24 fields · synced Sep 23, 2026