Cleared Traditional

Shina Syringe; Shina Safety Syringe

K231165 · Shina Med Corporation · General Hospital
Oct 2023
Decision
185d
Days
Class 2
Risk

About This 510(k) Submission

K231165 is an FDA 510(k) clearance for the Shina Syringe; Shina Safety Syringe, a Syringe, Antistick (Class II — Special Controls, product code MEG), submitted by Shina Med Corporation (Anseong-Si, KR). The FDA issued a Cleared decision on October 27, 2023, 185 days after receiving the submission on April 25, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K231165 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2023
Decision Date October 27, 2023
Days to Decision 185 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MEG — Syringe, Antistick
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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