Cleared Special

Sure-Fine Insulin Syringes

K210848 · Shina Med Corporation · General Hospital
Mar 2022
Decision
344d
Days
Class 2
Risk

About This 510(k) Submission

K210848 is an FDA 510(k) clearance for the Sure-Fine Insulin Syringes, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Shina Med Corporation (Anseong-Si, KR). The FDA issued a Cleared decision on March 1, 2022, 344 days after receiving the submission on March 22, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K210848 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 2021
Decision Date March 01, 2022
Days to Decision 344 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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