FDA 510(k)

EndoSerter-PL

Número K: K203586 · 2022-02-02

Data da decisão2022-02-02

Código do produtoOTZ

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

EndoSerter-PL is the device name listed in this FDA 510(k) record. The listed applicant is Corneagen, Inc.. It received FDA 510(k) clearance on 2022-02-02 under 510(k) number K203586. The device is classified under product code OTZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EndoSerter-PL?

EndoSerter-PL is a medical device that received FDA 510(k) clearance on 2022-02-02. The listed applicant is Corneagen, Inc.. The 510(k) number is K203586.

When did EndoSerter-PL receive FDA 510(k) clearance?

EndoSerter-PL received FDA 510(k) clearance on 2022-02-02, under 510(k) number K203586.

Who is the listed applicant for EndoSerter-PL?

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

What is the FDA product code for EndoSerter-PL?

The FDA product code for EndoSerter-PL is OTZ.

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