Cleared Traditional

eZSURE? Empty Fluid Container (models 426030, 426040, 426110)

K223674 · Epic Medical Pte. , Ltd. · General Hospital
Sep 2023
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K223674 is an FDA 510(k) clearance for the eZSURE? Empty Fluid Container (models 426030, 426040, 426110), a Container, I.v. (Class II — Special Controls, product code KPE), submitted by Epic Medical Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on September 1, 2023, 268 days after receiving the submission on December 7, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5025.

Submission Details

510(k) Number K223674 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 2022
Decision Date September 01, 2023
Days to Decision 268 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KPE — Container, I.v.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5025

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