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ECHELON LINEAR™ Stapler 30mm Stapler (GTX30) +8 more models

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K243276

by Ethicon Endo-Surgery, LLC

Identifiers

510(k) Number
K243276 FDA 510(k)
FDA Product Code
GDW FDA 510(k)
Models / Variants
ECHELON LINEAR™ Stapler 30mm Stapler (GTX30) FDA 510(k)EUDAMED
ECHELON LINEAR™ Stapler 60mm Stapler (GTX60) FDA 510(k)EUDAMED
ECHELON LINEAR™ Stapler 90mm Stapler (GTX90) FDA 510(k)EUDAMED
ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B) FDA 510(k)EUDAMED
ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G) FDA 510(k)EUDAMED
ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B) FDA 510(k)EUDAMED
ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G) FDA 510(k)EUDAMED
ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B) FDA 510(k)EUDAMED
ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G) FDA 510(k)EUDAMED

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 Linear Stapler is a linear cutting stapler designed for surgical anastomosis and tissue approximation. It delivers precise, controlled stapling and cutting along linear tissue margins, facilitating secure closure of hollow organs and vessels in minimally invasive procedures.

These devices are intended for single-use in surgical settings and are supplied sterile. Available in staple lengths of 30mm, 60mm, and 90mm, with reloads in blue or green configurations, they are regulated under FDA 510(k) clearance and EU MDR. Compatibility with laparoscopic and robotic platforms is noted, though MRI safety data is not specified.

Frequently asked questions

What are the staple lengths available for the Echelon Linear Stapler, and how do they differ in use cases?

The Echelon Linear Stapler is available in staple lengths of 30mm, 60mm, and 90mm. These lengths determine the width of tissue that can be stapled and cut in a single firing, making them suitable for different anatomical structures or surgical needs. For example, the 30mm stapler is ideal for smaller or more confined areas, while the 90mm provides a broader closure for larger tissue margins, such as those found in colorectal or vascular anastomoses.

Are the reloads for the Echelon Linear Stapler single-use, and if so, how should they be handled to maintain sterility?

Yes, the Echelon Linear Stapler and its reloads (e.g., GTXR30B, GTXR60G) are designed for single-use only. They are supplied sterile, so once opened or exposed to a non-sterile environment, they should not be reused. Reloads should be stored in their original packaging until ready for use, and the packaging should remain intact to preserve sterility.

What color options are available for the reloads, and does the color indicate any functional difference?

The reloads for the Echelon Linear Stapler come in two color configurations: blue and green (e.g., GTXR30B for blue and GTXR30G for green). The color does not indicate a functional difference—it is likely for inventory or tracking purposes to distinguish between reload types. Both blue and green reloads are compatible with their respective staple lengths (30mm, 60mm, or 90mm).

Can the Echelon Linear Stapler be used with laparoscopic or robotic platforms, and are there any special considerations for these settings?

Yes, the Echelon Linear Stapler is designed to be compatible with laparoscopic and robotic surgical platforms. While the device itself is not explicitly labeled as MRI-safe, its use in these settings assumes standard surgical precautions are followed, such as avoiding exposure to strong electromagnetic fields where not specified. Always verify platform compatibility and follow manufacturer guidelines for integration.

How is the regulatory status of the Echelon Linear Stapler determined, and what does this mean for purchasing or clinical use?

The Echelon Linear Stapler has received FDA 510(k) clearance and complies with EU MDR regulations. This means the device has undergone evaluation by regulatory authorities to demonstrate substantial equivalence to a predicate device (FDA) or compliance with EU safety and performance standards (MDR). For purchasing or clinical use, this indicates the device meets established regulatory requirements for safety and effectiveness, though clinicians should still follow local guidelines and institutional protocols.

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 (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ethicon Endo-Surgery, LLC

Sources (2)

  • FDA 510(k) K243276 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026