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EasyEndo Linear Cutting Stapler and Loading Unit for Single Use

FDA 510(k)

Class II (US FDA 510(k))

510(k) K143129

by Ezisurg Medical Co., Ltd.

Identifiers

510(k) Number
K143129 FDA 510(k)
FDA Product Code
GDW FDA 510(k)
Models / Variants
easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler FDA 510(k)
Loading Unit) 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 easyEndo Linear Cutting Stapler is a manual, single-use surgical instrument used in abdominal, gynecologic, and pediatric surgeries. It functions by placing two, triple-staggered rows of titanium staples into tissue while simultaneously dividing the tissue along a central line.

The device is supplied as a single-use instrument and is not intended for reuse. It is authorized under FDA 510K clearance with product code GDW and is used in general and plastic surgery procedures. The stapler comes with a loading unit and is designed for use in various surgical settings requiring tissue division and stapling.

Frequently asked questions

What is the easyEndo Linear Cutting Stapler used for?

The easyEndo Linear Cutting Stapler is a manual, single-use surgical instrument used in abdominal, gynecologic, and pediatric surgeries. It places two rows of triple-staggered titanium staples into tissue while simultaneously dividing tissue along a central line.

Is the easyEndo Linear Cutting Stapler reusable?

No, the easyEndo Linear Cutting Stapler is supplied as a single-use instrument and is not intended for reuse. It must be discarded after a single surgical procedure to ensure patient safety and device performance.

What regulatory approvals does the easyEndo Linear Cutting Stapler have?

The device is authorized under FDA 510K clearance with product code GDW. It has been determined to be substantially equivalent to predicate devices for use in general and plastic surgery procedures.

How is the easyEndo Linear Cutting Stapler supplied?

The stapler is supplied with a loading unit as a complete single-use system. It comes ready for use in various surgical settings requiring tissue division and stapling, with no additional preparation needed beyond standard sterile handling 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. Sources consulted: Disposable Linear Cutter Stapler | Ezisurg Medical, Manual Endoscopic Staplers | Ezisurg Medical, easyEndo Linear Cutting Stapler and Loading Unit for Single Use ..., Linear surgical stapler - easyEndo™ E-lite - EziSurg Medical - general ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ezisurg Medical Co., Ltd.

Sources (1)

  • FDA 510(k) K143129 24 fields · synced Sep 26, 2026