FDA 510(k)

VitreJect® Needle; OcuSafe® Needle

Número K: K230959 · 2023-09-14

Data da decisão2023-09-14

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

VitreJect® Needle; OcuSafe® 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 2023-09-14 under 510(k) number K230959. 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 VitreJect® Needle; OcuSafe® Needle?

VitreJect® Needle; OcuSafe® Needle is a medical device that received FDA 510(k) clearance on 2023-09-14. The listed applicant is Ocuject, LLC. The 510(k) number is K230959.

When did VitreJect® Needle; OcuSafe® Needle receive FDA 510(k) clearance?

VitreJect® Needle; OcuSafe® Needle received FDA 510(k) clearance on 2023-09-14, under 510(k) number K230959.

Who is the listed applicant for VitreJect® Needle; OcuSafe® 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 VitreJect® Needle; OcuSafe® Needle?

The FDA product code for VitreJect® Needle; OcuSafe® 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 K230372VitreJect Syringe K212544MiniLoad Syringe K212805SteriCap Mini Needle and Standard Needles K202432MiniLoad Syringe

Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: FMI)

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Fonte oficial

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