FDA 510(k)

ProSeal™ Transfer Injector (421120, 421130, 421140)

Número K: K251722 · 2025-12-05

Data da decisão2025-12-05

Código do produtoONB

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

ProSeal™ Transfer Injector (421120, 421130, 421140) is the device name listed in this FDA 510(k) record. The listed applicant is Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2025-12-05 under 510(k) number K251722. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ProSeal™ Transfer Injector (421120, 421130, 421140)?

ProSeal™ Transfer Injector (421120, 421130, 421140) is a medical device that received FDA 510(k) clearance on 2025-12-05. The listed applicant is Epic Medical Pte. , Ltd.. The 510(k) number is K251722.

When did ProSeal™ Transfer Injector (421120, 421130, 421140) receive FDA 510(k) clearance?

ProSeal™ Transfer Injector (421120, 421130, 421140) received FDA 510(k) clearance on 2025-12-05, under 510(k) number K251722.

Who is the listed applicant for ProSeal™ Transfer Injector (421120, 421130, 421140)?

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

What is the FDA product code for ProSeal™ Transfer Injector (421120, 421130, 421140)?

The FDA product code for ProSeal™ Transfer Injector (421120, 421130, 421140) is ONB.

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Outros registros que listam Epic Medical Pte. , Ltd. como candidato(a)

K252987ADRx® Admixture Device K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)K251814EZ™ IV Administration Set K252094eZSURE™ Empty Fluid Container K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)K243976ZeroClear™ Bag Access (423100)

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Dispositivos Relacionados (Código: ONB)

K253033Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorSimplivia Healthcare , Ltd.K250059BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)Becton, Dickinson and Company K251411Chemfort Female Luer Lock AdaptorSimplivia Healthcare , Ltd.K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)Epic Medical Pte. , Ltd.K243976ZeroClear™ Bag Access (423100)Epic Medical Pte. , Ltd.K240517ProSeal™ Vented Universal Vial AdaptorEpic Medical Pte. , Ltd.

Fonte oficial

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