FDA 510(k)

Flexible Intubation Video Endoscope – Sterile (FIVE-S)

Número K: K212656 · 2021-12-29

Data da decisão2021-12-29

Código do produtoEOQ

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Flexible Intubation Video Endoscope – Sterile (FIVE-S) is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy America. It received FDA 510(k) clearance on 2021-12-29 under 510(k) number K212656. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Flexible Intubation Video Endoscope – Sterile (FIVE-S)?

Flexible Intubation Video Endoscope – Sterile (FIVE-S) is a medical device that received FDA 510(k) clearance on 2021-12-29. The listed applicant is Karl Storz Endoscopy America. The 510(k) number is K212656.

When did Flexible Intubation Video Endoscope – Sterile (FIVE-S) receive FDA 510(k) clearance?

Flexible Intubation Video Endoscope – Sterile (FIVE-S) received FDA 510(k) clearance on 2021-12-29, under 510(k) number K212656.

Who is the listed applicant for Flexible Intubation Video Endoscope – Sterile (FIVE-S)?

The FDA 510(k) record lists Karl Storz Endoscopy America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flexible Intubation Video Endoscope – Sterile (FIVE-S)?

The FDA product code for Flexible Intubation Video Endoscope – Sterile (FIVE-S) is EOQ.

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Outros registros que listam Karl Storz Endoscopy America como candidato(a)

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Dispositivos Relacionados (Código: EOQ)

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Fonte oficial

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