FDA 510(k)

Endoscopic Linear Cutting Staplers and Loading Units for Single Use

Número K: K181620 · 2018-09-18

RequerenteEzisurg (Suzhou) Medical Co., Ltd.

Data da decisão2018-09-18

Código do produtoGDW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Endoscopic Linear Cutting Staplers and Loading Units for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Ezisurg (Suzhou) Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-09-18 under 510(k) number K181620. 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 Endoscopic Linear Cutting Staplers and Loading Units for Single Use?

Endoscopic Linear Cutting Staplers and Loading Units for Single Use is a medical device that received FDA 510(k) clearance on 2018-09-18. The listed applicant is Ezisurg (Suzhou) Medical Co., Ltd.. The 510(k) number is K181620.

When did Endoscopic Linear Cutting Staplers and Loading Units for Single Use receive FDA 510(k) clearance?

Endoscopic Linear Cutting Staplers and Loading Units for Single Use received FDA 510(k) clearance on 2018-09-18, under 510(k) number K181620.

Who is the listed applicant for Endoscopic Linear Cutting Staplers and Loading Units for Single Use?

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

What is the FDA product code for Endoscopic Linear Cutting Staplers and Loading Units for Single Use?

The FDA product code for Endoscopic Linear Cutting Staplers and Loading Units for Single Use is GDW.

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

K182217Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use

Dispositivos Relacionados (Código: GDW)

Fonte oficial

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