FDA 510(k)

SureFine Pen Needle

Número K: K250658 · 2025-04-03

Data da decisão2025-04-03

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

SureFine Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Shina Med Corporation. It received FDA 510(k) clearance on 2025-04-03 under 510(k) number K250658. 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 SureFine Pen Needle?

SureFine Pen Needle is a medical device that received FDA 510(k) clearance on 2025-04-03. The listed applicant is Shina Med Corporation. The 510(k) number is K250658.

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

SureFine Pen Needle received FDA 510(k) clearance on 2025-04-03, under 510(k) number K250658.

Who is the listed applicant for SureFine Pen Needle?

The FDA 510(k) record lists Shina Med Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SureFine Pen Needle?

The FDA product code for SureFine Pen Needle is FMI.

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Outros registros que listam Shina Med Corporation como candidato(a)

K250510Sure-Fine Insulin Syringes K231165Shina Syringe; Shina Safety Syringe K210848Sure-Fine Insulin Syringes K191531Sure-Fine Insulin Syringes K152879Sure-Fine Insulin Syringes K152877SureFine Pen Needle

Ver todos os 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.

Fonte oficial

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