FDA 510(k)

ProSeal Transfer Injector (421120, 421130, 421140)

K-Number: K251722 · 2025-12-05

Decision Date2025-12-05

Product CodeONB

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Epic Medical Pte. , Ltd.. The 510(k) number is K251722.

When was ProSeal Transfer Injector (421120, 421130, 421140) approved by the FDA?

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

What company makes ProSeal Transfer Injector (421120, 421130, 421140)?

ProSeal Transfer Injector (421120, 421130, 421140) is manufactured by Epic Medical Pte. , Ltd..

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.

Other Devices by Epic Medical Pte. , Ltd.

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K170706Equashield Closed System drug Transfer Device (CSTD)Equashield Medical , Ltd. K170680TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant K181221BD PhaSeal Optima Closed System Transfer DeviceBecton, Dickinson and Company K180489TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant K173477ChemoCLAVE Cytotoxic Medication Preparation and Delivery SystemIcu Medical, Inc. K180574Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial AdaptorJ & J Solutions, Inc. D/B/A/ Corvida Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.