FDA 510(k)

VitreJect® Needle; OcuSafe® Needle

N.º K: K230959 · 2023-09-14

Fecha de decisión2023-09-14

Código de productoFMI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Ocuject, LLC como solicitante

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 los 8 dispositivos →

Dispositivos relacionados (Código: FMI)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

Fuente oficial

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