FDA 510(k) Applications Submitted by Epic Medical Pte. Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K240171 01/22/2024 ProSealÖ Injector Plus (Model no. 421050) Epic Medical Pte. Ltd.
K240433 02/14/2024 ProSealÖ Injection Site Extended Male Luer Lock (422140) Epic Medical Pte. Ltd.
K240517 02/23/2024 ProSealÖ Vented Universal Vial Adaptor Epic Medical Pte. Ltd.
K251340 04/30/2025 ProSealÖ Bag Spike with Additive Port (423370ST, 423370) Epic Medical Pte. Ltd.
K241442 05/22/2024 eZSUREÖ Empty Fluid Container with ProSealÖ Injection Site Epic Medical Pte. Ltd.
K241476 05/24/2024 ToxiSealÖ Vial Adaptor with External Flip Balloon Epic Medical Pte. Ltd.
K201626 06/16/2020 Safety Subcutaneous Infusion Set Epic Medical Pte. Ltd.
K241735 06/17/2024 ProSealÖ In Line Pump Set (423850) Epic Medical Pte. Ltd.
K241823 06/24/2024 ToxiSealÖ Vial Adaptor Epic Medical Pte. Ltd.
K241988 07/08/2024 ProSealÖ Closed System Bag Access Epic Medical Pte. Ltd.
K242152 07/23/2024 SMARTeZÖ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) Epic Medical Pte. Ltd.
K192075 08/02/2019 ProSealÖ Closed System drug Transfer Device (CSTD) Epic Medical Pte. Ltd.
K243976 12/23/2024 ZeroClearÖ Bag Access (423100) Epic Medical Pte. Ltd.


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