Cleared Traditional

CLICKFINE PEN NEEDLE

K131125 · Ypsomed AG · General Hospital
Jul 2013
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K131125 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 July 5, 2013, 74 days after receiving the submission on April 22, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K131125 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2013
Decision Date July 05, 2013
Days to Decision 74 days
Submission Type Traditional
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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