FDA 510(k)

easyPPHTM Hemorrhoidal Stapler for Single Use

Número K: K183477 · 2019-02-11

Data da decisão2019-02-11

Código do produtoGDW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

easyPPHTM Hemorrhoidal Stapler for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Ezisurg Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-02-11 under 510(k) number K183477. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the easyPPHTM Hemorrhoidal Stapler for Single Use?

easyPPHTM Hemorrhoidal Stapler for Single Use is a medical device that received FDA 510(k) clearance on 2019-02-11. The listed applicant is Ezisurg Medical Co., Ltd.. The 510(k) number is K183477.

When did easyPPHTM Hemorrhoidal Stapler for Single Use receive FDA 510(k) clearance?

easyPPHTM Hemorrhoidal Stapler for Single Use received FDA 510(k) clearance on 2019-02-11, under 510(k) number K183477.

Who is the listed applicant for easyPPHTM Hemorrhoidal Stapler for Single Use?

The FDA 510(k) record lists Ezisurg Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for easyPPHTM Hemorrhoidal Stapler for Single Use?

The FDA product code for easyPPHTM Hemorrhoidal Stapler for Single Use is GDW.

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Outros registros que listam Ezisurg Medical Co., Ltd. como candidato(a)

K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges K210909easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use K181657easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use K172960easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use

Dispositivos Relacionados (Código: GDW)

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