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FDA 510(k)

SteriCap Mini Needle

Número K: K183016 · 2019-05-07

RequerenteOcujet, LLC
Data da decisão2019-05-07
Código do produtoFMI
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

SteriCap Mini Needle is the device name listed in this FDA 510(k) record. The listed applicant is Ocujet, LLC. It received FDA 510(k) clearance on 2019-05-07 under 510(k) number K183016. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SteriCap Mini Needle?

SteriCap Mini Needle is a medical device that received FDA 510(k) clearance on 2019-05-07. The listed applicant is Ocujet, LLC. The 510(k) number is K183016.

When did SteriCap Mini Needle receive FDA 510(k) clearance?

SteriCap Mini Needle received FDA 510(k) clearance on 2019-05-07, under 510(k) number K183016.

Who is the listed applicant for SteriCap Mini Needle?

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

What is the FDA product code for SteriCap Mini Needle?

The FDA product code for SteriCap Mini Needle is FMI.

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Dispositivos Relacionados (Código: FMI)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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