Cleared Special

CLICKFINE PEN NEEDLE

K100436 · Ypsomed AG · General Hospital
Apr 2010
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K100436 is an FDA 510(k) clearance for the CLICKFINE PEN NEEDLE, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Ypsomed AG (Burgdorf, CH). The FDA issued a Cleared decision on April 30, 2010, 73 days after receiving the submission on February 16, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K100436 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2010
Decision Date April 30, 2010
Days to Decision 73 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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