FDA 510(k)

Sterile Safety Hypodermic Needles for Single Use

N.º K: K231723 · 2023-09-08

SolicitanteWepon Medical Technology Co., Ltd.

Fecha de decisión2023-09-08

Código de productoFMI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sterile Safety Hypodermic Needles for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Wepon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K231723. 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 Sterile Safety Hypodermic Needles for Single Use?

Sterile Safety Hypodermic Needles for Single Use is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Wepon Medical Technology Co., Ltd.. The 510(k) number is K231723.

When did Sterile Safety Hypodermic Needles for Single Use receive FDA 510(k) clearance?

Sterile Safety Hypodermic Needles for Single Use received FDA 510(k) clearance on 2023-09-08, under 510(k) number K231723.

Who is the listed applicant for Sterile Safety Hypodermic Needles for Single Use?

The FDA 510(k) record lists Wepon Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Safety Hypodermic Needles for Single Use?

The FDA product code for Sterile Safety Hypodermic Needles for Single Use is FMI.

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Otros registros que enlistan a Wepon Medical Technology Co., Ltd. como solicitante

K231727Sterile Auto-Disable Syringes with/without Needle for Single Use K231720Sterile Hypodermic Needles for Single Use K231729Sterile syringes for single use with/without needle K212299Medical Surgical Mask

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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