FDA 510(k)

Mini Needle

Número K: K170768 · 2017-07-10

Data da decisão2017-07-10

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Mini Needle is the device name listed in this FDA 510(k) record. The listed applicant is Ocuject, LLC. It received FDA 510(k) clearance on 2017-07-10 under 510(k) number K170768. 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 Mini Needle?

Mini Needle is a medical device that received FDA 510(k) clearance on 2017-07-10. The listed applicant is Ocuject, LLC. The 510(k) number is K170768.

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

Mini Needle received FDA 510(k) clearance on 2017-07-10, under 510(k) number K170768.

Who is the listed applicant for Mini Needle?

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

What is the FDA product code for Mini Needle?

The FDA product code for Mini Needle is FMI.

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Outros registros que listam Ocuject, LLC como candidato(a)

K242956LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle K233343SteriCap Safety Needle; VitreJect Safety Needle K230959VitreJect® Needle; OcuSafe® Needle K230372VitreJect Syringe K212544MiniLoad Syringe K212805SteriCap Mini Needle and Standard Needles

Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: FMI)

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