FDA 510(k)

Safety Pen Needle

Número K: K253622 · 2026-03-18

RequerenteNingbo Medsun Medical Co., Ltd.

Data da decisão2026-03-18

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Ningbo Medsun Medical Co., Ltd. como candidato(a)

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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.

Fonte oficial

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