FDA 510(k)

Amsel Endo Occluder

Número K: K180650 · 2018-11-15

Data da decisão2018-11-15

Código do produtoFZP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Amsel Endo Occluder is the device name listed in this FDA 510(k) record. The listed applicant is Amsel Medical Corporation. It received FDA 510(k) clearance on 2018-11-15 under 510(k) number K180650. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Amsel Endo Occluder?

Amsel Endo Occluder is a medical device that received FDA 510(k) clearance on 2018-11-15. The listed applicant is Amsel Medical Corporation. The 510(k) number is K180650.

When did Amsel Endo Occluder receive FDA 510(k) clearance?

Amsel Endo Occluder received FDA 510(k) clearance on 2018-11-15, under 510(k) number K180650.

Who is the listed applicant for Amsel Endo Occluder?

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

What is the FDA product code for Amsel Endo Occluder?

The FDA product code for Amsel Endo Occluder is FZP.

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