Cleared Traditional

Medline Luer Lock Syringes

K230235 · Medline Industries, LP · General Hospital
Feb 2024
Decision
385d
Days
Class 2
Risk

About This 510(k) Submission

K230235 is an FDA 510(k) clearance for the Medline Luer Lock Syringes, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Medline Industries, LP (Nortfield, US). The FDA issued a Cleared decision on February 16, 2024, 385 days after receiving the submission on January 27, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K230235 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2023
Decision Date February 16, 2024
Days to Decision 385 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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