510(k) K202570

Insulin Syringe, Insulin Syringe with Safety Retractable by Jiangsu Micsafe Medical Technology Co., Ltd. — Product Code MEG

K202570 is an FDA 510(k) premarket notification submitted by Jiangsu Micsafe Medical Technology Co., Ltd. for the device "Insulin Syringe, Insulin Syringe with Safety Retractable". The FDA issued a decision of Substantially Equivalent on July 2, 2021. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Jiangsu Micsafe Medical Technology Co., Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2021
Date Received
September 4, 2020
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