FDA 510(k)

Single Use Irrigation bipolar cable

Número K: K211170 · 2021-10-19

RequerenteModern Medical Equipment Manufacturing, Ltd.

Data da decisão2021-10-19

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Single Use Irrigation bipolar cable is the device name listed in this FDA 510(k) record. The listed applicant is Modern Medical Equipment Manufacturing, Ltd.. It received FDA 510(k) clearance on 2021-10-19 under 510(k) number K211170. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Single Use Irrigation bipolar cable?

Single Use Irrigation bipolar cable is a medical device that received FDA 510(k) clearance on 2021-10-19. The listed applicant is Modern Medical Equipment Manufacturing, Ltd.. The 510(k) number is K211170.

When did Single Use Irrigation bipolar cable receive FDA 510(k) clearance?

Single Use Irrigation bipolar cable received FDA 510(k) clearance on 2021-10-19, under 510(k) number K211170.

Who is the listed applicant for Single Use Irrigation bipolar cable?

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

What is the FDA product code for Single Use Irrigation bipolar cable?

The FDA product code for Single Use Irrigation bipolar cable is GEI.

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