510(k) K231165

Shina Syringe; Shina Safety Syringe by Shina Med Corporation — Product Code MEG

K231165 is an FDA 510(k) premarket notification submitted by Shina Med Corporation for the device "Shina Syringe; Shina Safety Syringe". The FDA issued a decision of Substantially Equivalent on October 27, 2023. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Shina Med Corporation has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2023
Date Received
April 25, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Antistick
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type