Cleared Traditional

CLICKFINE AUTOPROTECT PEN NEEDLE

K110312 · Ypsomed AG · General Hospital
Jan 2012
Decision
358d
Days
Class 2
Risk

About This 510(k) Submission

K110312 is an FDA 510(k) clearance for the CLICKFINE AUTOPROTECT 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 January 26, 2012, 358 days after receiving the submission on February 2, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K110312 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2011
Decision Date January 26, 2012
Days to Decision 358 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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