Cleared Traditional

VitreJect? Needle; OcuSafe? Needle

K230959 · Ocuject, LLC · General Hospital
Sep 2023
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K230959 is an FDA 510(k) clearance for the VitreJect? Needle; OcuSafe? Needle, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Ocuject, LLC (Newport Beach, US). The FDA issued a Cleared decision on September 14, 2023, 163 days after receiving the submission on April 4, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K230959 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2023
Decision Date September 14, 2023
Days to Decision 163 days
Submission Type Traditional
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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