FDA 510(k)

ATOVEN- Fio Laser Reutilizável

Número K: K152667 · 2016-06-09

Data da decisão2016-06-09

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ATOVEN-Reusable Laser Fiber is the device name listed in this FDA 510(k) record. The listed applicant is Diotech CO. It received FDA 510(k) clearance on 2016-06-09 under 510(k) number K152667. 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 ATOVEN-Reusable Laser Fiber?

ATOVEN-Reusable Laser Fiber is a medical device that received FDA 510(k) clearance on 2016-06-09. The listed applicant is Diotech CO. The 510(k) number is K152667.

When did ATOVEN-Reusable Laser Fiber receive FDA 510(k) clearance?

ATOVEN-Reusable Laser Fiber received FDA 510(k) clearance on 2016-06-09, under 510(k) number K152667.

Who is the listed applicant for ATOVEN-Reusable Laser Fiber?

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

What is the FDA product code for ATOVEN-Reusable Laser Fiber?

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

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