Cleared Abbreviated

SteriCap Safety Needle; VitreJect Safety Needle

K233343 · Ocuject, LLC · General Hospital
Nov 2023
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K233343 is an FDA 510(k) clearance for the SteriCap Safety Needle; VitreJect Safety 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 November 27, 2023, 59 days after receiving the submission on September 29, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K233343 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2023
Decision Date November 27, 2023
Days to Decision 59 days
Submission Type Abbreviated
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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