510(k) K211329

Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle by Jiangsu Kangbao Medical Equipment Co., Ltd. — Product Code MEG

K211329 is an FDA 510(k) premarket notification submitted by Jiangsu Kangbao Medical Equipment Co., Ltd. for the device "Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle". The FDA issued a decision of Substantially Equivalent on November 15, 2021. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Jiangsu Kangbao Medical Equipment Co., Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2021
Date Received
May 3, 2021
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