ToxiSeal Vial Adapter with External Balloon

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K222929 ↗

FDA Product Code

ONB

FDA applicant

Epic Medical Pte. , Ltd.

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Epic Medical Pte., Ltd. →