FDA 510(k)

InnoVoyce Laser Fiber

Número K: K220793 · 2022-05-25

Data da decisão2022-05-25

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

InnoVoyce Laser Fiber is the device name listed in this FDA 510(k) record. The listed applicant is Innovoyce, LLC. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K220793. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the InnoVoyce Laser Fiber?

InnoVoyce Laser Fiber is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Innovoyce, LLC. The 510(k) number is K220793.

When did InnoVoyce Laser Fiber receive FDA 510(k) clearance?

InnoVoyce Laser Fiber received FDA 510(k) clearance on 2022-05-25, under 510(k) number K220793.

Who is the listed applicant for InnoVoyce Laser Fiber?

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

What is the FDA product code for InnoVoyce Laser Fiber?

The FDA product code for InnoVoyce Laser Fiber is GEX. This falls under the Gastroenterology category.

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