510(k) K222452

Disposable Automatically Retractable Safety Syringes (with detachable needle) by Shantou Wealy Medical Instrument Co.,Ltd — Product Code MEG

K222452 is an FDA 510(k) premarket notification submitted by Shantou Wealy Medical Instrument Co.,Ltd for the device "Disposable Automatically Retractable Safety Syringes (with detachable needle)". The FDA issued a decision of Substantially Equivalent on November 23, 2022. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Shantou Wealy Medical Instrument Co.,Ltd has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2022
Date Received
August 15, 2022
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