FDA 510(k)

Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers

Номер K: K211811 · 2022-03-03

ЗаявительWuxi Beien Surgery Device Co., Ltd.

Дата решения2022-03-03

Код продуктаGDW

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers is the device name listed in this FDA 510(k) record. The listed applicant is Wuxi Beien Surgery Device Co., Ltd.. It received FDA 510(k) clearance on 2022-03-03 under 510(k) number K211811. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers?

Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers is a medical device that received FDA 510(k) clearance on 2022-03-03. The listed applicant is Wuxi Beien Surgery Device Co., Ltd.. The 510(k) number is K211811.

When did Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers receive FDA 510(k) clearance?

Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers received FDA 510(k) clearance on 2022-03-03, under 510(k) number K211811.

Who is the listed applicant for Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers?

The FDA 510(k) record lists Wuxi Beien Surgery Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers?

The FDA product code for Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers is GDW.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: GDW)

Официальный источник

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