Cleared Traditional

ProSeal? Vented Universal Vial Adaptor

K240517 · Epic Medical Pte. , Ltd. · General Hospital

Dec 2024

Decision

307d

Days

Class 2

Risk

About This 510(k) Submission

K240517 is an FDA 510(k) clearance for the ProSeal? Vented Universal Vial Adaptor, a Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (Class II — Special Controls, product code ONB), submitted by Epic Medical Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on December 26, 2024, 307 days after receiving the submission on February 23, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K240517 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 23, 2024
Decision Date	December 26, 2024
Days to Decision	307 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	ONB — Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5440
Definition	Reconstitute And Transfer Antineoplastic And Other Hazardous Drugs In Healthcare Setting Indicated To Reduce Exposure Of Healthcare Personnel To Chemotherapy Agents In Healthcare Setting.