FDA 510(k)

GastroFlush

Número K: K180605 · 2018-10-24

RequerenteBionix Development Corporation

Data da decisão2018-10-24

Código do produtoKNT

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

GastroFlush is the device name listed in this FDA 510(k) record. The listed applicant is Bionix Development Corporation. It received FDA 510(k) clearance on 2018-10-24 under 510(k) number K180605. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GastroFlush?

GastroFlush is a medical device that received FDA 510(k) clearance on 2018-10-24. The listed applicant is Bionix Development Corporation. The 510(k) number is K180605.

When did GastroFlush receive FDA 510(k) clearance?

GastroFlush received FDA 510(k) clearance on 2018-10-24, under 510(k) number K180605.

Who is the listed applicant for GastroFlush?

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

What is the FDA product code for GastroFlush?

The FDA product code for GastroFlush is KNT.

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