FDA 510(k)

NavaClick Injection System

Número K: K231877 · 2023-11-30

Data da decisão2023-11-30

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

NavaClick Injection System is the device name listed in this FDA 510(k) record. The listed applicant is Lineage Biomedical, Inc.. It received FDA 510(k) clearance on 2023-11-30 under 510(k) number K231877. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NavaClick Injection System?

NavaClick Injection System is a medical device that received FDA 510(k) clearance on 2023-11-30. The listed applicant is Lineage Biomedical, Inc.. The 510(k) number is K231877.

When did NavaClick Injection System receive FDA 510(k) clearance?

NavaClick Injection System received FDA 510(k) clearance on 2023-11-30, under 510(k) number K231877.

Who is the listed applicant for NavaClick Injection System?

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

What is the FDA product code for NavaClick Injection System?

The FDA product code for NavaClick Injection System is FMF.

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Fonte oficial

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