FDA 510(k)

TubeClear Control Box and Clearing Stem

Número K: K163092 · 2016-11-30

Data da decisão2016-11-30

Código do produtoKNT

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

TubeClear Control Box and Clearing Stem is the device name listed in this FDA 510(k) record. The listed applicant is Actuated Medical, Inc.. It received FDA 510(k) clearance on 2016-11-30 under 510(k) number K163092. 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 TubeClear Control Box and Clearing Stem?

TubeClear Control Box and Clearing Stem is a medical device that received FDA 510(k) clearance on 2016-11-30. The listed applicant is Actuated Medical, Inc.. The 510(k) number is K163092.

When did TubeClear Control Box and Clearing Stem receive FDA 510(k) clearance?

TubeClear Control Box and Clearing Stem received FDA 510(k) clearance on 2016-11-30, under 510(k) number K163092.

Who is the listed applicant for TubeClear Control Box and Clearing Stem?

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

What is the FDA product code for TubeClear Control Box and Clearing Stem?

The FDA product code for TubeClear Control Box and Clearing Stem is KNT.

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Fonte oficial

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