FDA 510(k)

Instrument basket, for EndoEYE

Número K: K171692 · 2018-04-02

Data da decisão2018-04-02

Código do produtoKCT

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Instrument basket, for EndoEYE is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2018-04-02 under 510(k) number K171692. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Instrument basket, for EndoEYE?

Instrument basket, for EndoEYE is a medical device that received FDA 510(k) clearance on 2018-04-02. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K171692.

When did Instrument basket, for EndoEYE receive FDA 510(k) clearance?

Instrument basket, for EndoEYE received FDA 510(k) clearance on 2018-04-02, under 510(k) number K171692.

Who is the listed applicant for Instrument basket, for EndoEYE?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Instrument basket, for EndoEYE?

The FDA product code for Instrument basket, for EndoEYE is KCT.

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Fonte oficial

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