Cleared Traditional

SureFine Pen Needle

K152877 · Shina Med Corporation · General Hospital
Jun 2016
Decision
251d
Days
Class 2
Risk

About This 510(k) Submission

K152877 is an FDA 510(k) clearance for the SureFine Pen Needle, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Shina Med Corporation (Anseong-Si, KR). The FDA issued a Cleared decision on June 7, 2016, 251 days after receiving the submission on September 30, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K152877 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2015
Decision Date June 07, 2016
Days to Decision 251 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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