Cleared Special

Clickfine AutoProtect Pen Needle

K152514 · Ypsomed AG · General Hospital
Nov 2015
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K152514 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 November 18, 2015, 77 days after receiving the submission on September 2, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K152514 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 2015
Decision Date November 18, 2015
Days to Decision 77 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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