Cleared Special

Clickfine Pen Needle, Penfine Classic Pen Needle

K171984 · Ypsomed AG · General Hospital
Oct 2017
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K171984 is an FDA 510(k) clearance for the Clickfine Pen Needle, Penfine Classic 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 October 11, 2017, 103 days after receiving the submission on June 30, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K171984 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2017
Decision Date October 11, 2017
Days to Decision 103 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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