FDA 510(k)

iSurg

Número K: K170054 · 2017-10-02

RequerenteJaco, LLC Dba Macan Manufacturing and Bna Burz North America

Data da decisão2017-10-02

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

iSurg is the device name listed in this FDA 510(k) record. The listed applicant is Jaco, LLC Dba Macan Manufacturing and Bna Burz North America. It received FDA 510(k) clearance on 2017-10-02 under 510(k) number K170054. 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 iSurg?

iSurg is a medical device that received FDA 510(k) clearance on 2017-10-02. The listed applicant is Jaco, LLC Dba Macan Manufacturing and Bna Burz North America. The 510(k) number is K170054.

When did iSurg receive FDA 510(k) clearance?

iSurg received FDA 510(k) clearance on 2017-10-02, under 510(k) number K170054.

Who is the listed applicant for iSurg?

The FDA 510(k) record lists Jaco, LLC Dba Macan Manufacturing and Bna Burz North America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iSurg?

The FDA product code for iSurg is GEI.

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