Cleared Special

BD PEN NEEDLE

K110105 · Becton, Dickinson and Company (BD) · General Hospital
Apr 2011
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K110105 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 and Company (BD) (Franklin Lakes, US). The FDA issued a Cleared decision on April 28, 2011, 105 days after receiving the submission on January 13, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K110105 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2011
Decision Date April 28, 2011
Days to Decision 105 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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