Cleared Special

MiniLoad Syringe

K212544 · Ocuject, LLC · General Hospital
Oct 2021
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K212544 is an FDA 510(k) clearance for the MiniLoad Syringe, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Ocuject, LLC (Newport Beach, US). The FDA issued a Cleared decision on October 13, 2021, 62 days after receiving the submission on August 12, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K212544 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 2021
Decision Date October 13, 2021
Days to Decision 62 days
Submission Type Special
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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