Cleared Special

EZ-IO Intraosseous Vascular Access System

K231924 · Teleflex Medical · General Hospital
Jul 2023
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K231924 is an FDA 510(k) clearance for the EZ-IO Intraosseous Vascular Access System, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on July 25, 2023, 25 days after receiving the submission on June 30, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K231924 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2023
Decision Date July 25, 2023
Days to Decision 25 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMI — Needle, Hypodermic, Single Lumen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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