FDA 510(k)

EnlightenVue Microendoscopy System

Número K: K192300 · 2020-03-20

Data da decisão2020-03-20

Código do produtoGCJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

EnlightenVue Microendoscopy System is the device name listed in this FDA 510(k) record. The listed applicant is Enlightenvue, Inc.. It received FDA 510(k) clearance on 2020-03-20 under 510(k) number K192300. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EnlightenVue Microendoscopy System?

EnlightenVue Microendoscopy System is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Enlightenvue, Inc.. The 510(k) number is K192300.

When did EnlightenVue Microendoscopy System receive FDA 510(k) clearance?

EnlightenVue Microendoscopy System received FDA 510(k) clearance on 2020-03-20, under 510(k) number K192300.

Who is the listed applicant for EnlightenVue Microendoscopy System?

The FDA 510(k) record lists Enlightenvue, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EnlightenVue Microendoscopy System?

The FDA product code for EnlightenVue Microendoscopy System is GCJ.

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