FDA 510(k)

ORION

Número K: K161503 · 2016-08-26

Data da decisão2016-08-26

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ORION is the device name listed in this FDA 510(k) record. The listed applicant is Yerim Engineering Co., Ltd.. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K161503. 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 ORION?

ORION is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Yerim Engineering Co., Ltd.. The 510(k) number is K161503.

When did ORION receive FDA 510(k) clearance?

ORION received FDA 510(k) clearance on 2016-08-26, under 510(k) number K161503.

Who is the listed applicant for ORION?

The FDA 510(k) record lists Yerim Engineering Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORION?

The FDA product code for ORION is GEX. This falls under the Gastroenterology category.

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