FDA 510(k)

Safety Pen Needle

N.º K: K253622 · 2026-03-18

SolicitanteNingbo Medsun Medical Co., Ltd.

Fecha de decisión2026-03-18

Código de productoFMI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Safety Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Medsun Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-03-18 under 510(k) number K253622. 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 Safety Pen Needle?

Safety Pen Needle is a medical device that received FDA 510(k) clearance on 2026-03-18. The listed applicant is Ningbo Medsun Medical Co., Ltd.. The 510(k) number is K253622.

When did Safety Pen Needle receive FDA 510(k) clearance?

Safety Pen Needle received FDA 510(k) clearance on 2026-03-18, under 510(k) number K253622.

Who is the listed applicant for Safety Pen Needle?

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

What is the FDA product code for Safety Pen Needle?

The FDA product code for Safety Pen Needle is FMI.

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Otros registros que enlistan a Ningbo Medsun Medical Co., Ltd. como solicitante

K253605Safety Heel Lancet K242627Safety Lancet K242316Safety Lancet K232330Lancing System K221178Disposable Insulin Pen Needle K222090Safety Lancet

Ver todos los 7 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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