Cleared Special

BD PEN NEEDLE

K123300 · Becton, Dickinson & CO · General Hospital
Jan 2013
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K123300 is an FDA 510(k) clearance for the BD PEN NEEDLE, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Becton, Dickinson & CO (Franklin Lakes, US). The FDA issued a Cleared decision on January 18, 2013, 87 days after receiving the submission on October 23, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K123300 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 2012
Decision Date January 18, 2013
Days to Decision 87 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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