Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter …

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K211811

Identifiers

510(k) Number: K211811 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)

These devices are endoscopic staplers and reload units designed for use in surgical procedures. They include disposable hemorrhoidal cutter staplers, linear cutter staplers, and circular staplers.

The devices are supplied sterile and intended for single use. They are not reusable and are not MRI safe. The manufacturer is Wuxi Beien Surgery Device Co., Ltd.

Frequently asked questions

What types of endoscopic staplers are included in this product line?

The product line includes disposable hemorrhoidal cutter staplers, disposable linear cutter staplers, and disposable circular staplers. These devices are designed for use in surgical procedures.

Are these staplers intended for single use?

Yes, the devices are intended for single use and are supplied sterile. They are not reusable and are not MRI safe.

Who is the manufacturer of these endoscopic staplers?

The devices are manufactured by Wuxi Beien Surgery Device Co., Ltd.

What is the regulatory status of these devices?

The devices have received FDA 510(k) clearance and are also authorized under MDD and MDR regulations.

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

MDD

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K211811	Class II	Active

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Manufacturer

Manufacturer: Wuxi Beien Surgery Device Co., Ltd.

Sources (2)

FDA 510(k) K211811 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 18, 2026