Cleared Special

SteriCap Mini Needle and Standard Needles

K212805 · Ocuject, LLC · General Hospital
Sep 2021
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K212805 is an FDA 510(k) clearance for the SteriCap Mini Needle and Standard Needles, 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 30, 2021, 28 days after receiving the submission on September 2, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K212805 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 2021
Decision Date September 30, 2021
Days to Decision 28 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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