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FDA 510(k)

UltiCare Disposable Pen Needles

Número K: K213407 · 2021-12-16

RequerenteUltimed Incorporated
Data da decisão2021-12-16
Código do produtoFMI
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

UltiCare Disposable Pen Needles is the device name listed in this FDA 510(k) record. The listed applicant is Ultimed Incorporated. It received FDA 510(k) clearance on 2021-12-16 under 510(k) number K213407. 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 UltiCare Disposable Pen Needles?

UltiCare Disposable Pen Needles is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is Ultimed Incorporated. The 510(k) number is K213407.

When did UltiCare Disposable Pen Needles receive FDA 510(k) clearance?

UltiCare Disposable Pen Needles received FDA 510(k) clearance on 2021-12-16, under 510(k) number K213407.

Who is the listed applicant for UltiCare Disposable Pen Needles?

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

What is the FDA product code for UltiCare Disposable Pen Needles?

The FDA product code for UltiCare Disposable Pen Needles is FMI.

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Dispositivos Relacionados (Código: FMI)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed 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.

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