Cleared Traditional

Top Fine Pen Needle

K152410 · Medexel Co.,Ltd · General Hospital

Feb 2016

Decision

160d

Days

Class 2

Risk

About This 510(k) Submission

K152410 is an FDA 510(k) clearance for the Top Fine Pen Needle, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Medexel Co.,Ltd (Anseong-Si, KR). The FDA issued a Cleared decision on February 2, 2016, 160 days after receiving the submission on August 26, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K152410 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 26, 2015
Decision Date	February 02, 2016
Days to Decision	160 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF