FDA 510(k)

Instrument tray, for semi-rigid ureteroscope

Número K: K203492 · 2021-09-15

Data da decisão2021-09-15

Código do produtoKCT

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Instrument tray, for semi-rigid ureteroscope 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 2021-09-15 under 510(k) number K203492. 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 tray, for semi-rigid ureteroscope?

Instrument tray, for semi-rigid ureteroscope is a medical device that received FDA 510(k) clearance on 2021-09-15. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K203492.

When did Instrument tray, for semi-rigid ureteroscope receive FDA 510(k) clearance?

Instrument tray, for semi-rigid ureteroscope received FDA 510(k) clearance on 2021-09-15, under 510(k) number K203492.

Who is the listed applicant for Instrument tray, for semi-rigid ureteroscope?

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 tray, for semi-rigid ureteroscope?

The FDA product code for Instrument tray, for semi-rigid ureteroscope is KCT.

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Outros registros que listam Olympus Winter & Ibe GmbH como candidato(a)

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Fonte oficial

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