510(k) K191490

Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe by Jiangsu Caina Medical Co.,Ltd — Product Code MEG

K191490 is an FDA 510(k) premarket notification submitted by Jiangsu Caina Medical Co.,Ltd for the device "Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe". The FDA issued a decision of Substantially Equivalent on October 3, 2019. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Jiangsu Caina Medical Co.,Ltd has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2019
Date Received
June 5, 2019
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