Cleared Special

Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)

K150662 · Ypsomed AG · General Hospital

Jun 2015

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K150662 is an FDA 510(k) clearance for the Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated), 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 June 9, 2015, 88 days after receiving the submission on March 13, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K150662 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 2015
Decision Date	June 09, 2015
Days to Decision	88 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Summary PDF