Cleared Special

SureFine Pen Needle

K250658 · Shina Med Corporation · General Hospital
Apr 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K250658 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, KR). The FDA issued a Cleared decision on April 3, 2025, 29 days after receiving the submission on March 5, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K250658 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2025
Decision Date April 03, 2025
Days to Decision 29 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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