FDA 510(k)

Medilas H Laser Fibers

Número K: K161771 · 2016-07-28

Data da decisão2016-07-28

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medilas H Laser Fibers is the device name listed in this FDA 510(k) record. The listed applicant is Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K161771. 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 Medilas H Laser Fibers?

Medilas H Laser Fibers is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is Dornier Medtech America, Inc.. The 510(k) number is K161771.

When did Medilas H Laser Fibers receive FDA 510(k) clearance?

Medilas H Laser Fibers received FDA 510(k) clearance on 2016-07-28, under 510(k) number K161771.

Who is the listed applicant for Medilas H Laser Fibers?

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

What is the FDA product code for Medilas H Laser Fibers?

The FDA product code for Medilas H Laser Fibers is GEX. This falls under the Gastroenterology category.

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