FDA 510(k)

Celeris, Disposable Sinus Debrider

Número K: K212650 · 2022-01-19

Data da decisão2022-01-19

Código do produtoERL

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Celeris, Disposable Sinus Debrider is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2022-01-19 under 510(k) number K212650. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Celeris, Disposable Sinus Debrider?

Celeris, Disposable Sinus Debrider is a medical device that received FDA 510(k) clearance on 2022-01-19. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K212650.

When did Celeris, Disposable Sinus Debrider receive FDA 510(k) clearance?

Celeris, Disposable Sinus Debrider received FDA 510(k) clearance on 2022-01-19, under 510(k) number K212650.

Who is the listed applicant for Celeris, Disposable Sinus Debrider?

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

What is the FDA product code for Celeris, Disposable Sinus Debrider?

The FDA product code for Celeris, Disposable Sinus Debrider is ERL.

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Fonte oficial

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