FDA 510(k)

SteriCap Mini Needle

N.º K: K183016 · 2019-05-07

Fecha de decisión2019-05-07

Código de productoFMI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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)

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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