510(k) K220204

Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle by Anhui Tiankang Medical Technology Co., Ltd. — Product Code FMF

K220204 is an FDA 510(k) premarket notification submitted by Anhui Tiankang Medical Technology Co., Ltd. for the device "Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle". The FDA issued a decision of Substantially Equivalent on July 14, 2022. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Anhui Tiankang Medical Technology Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2022
Date Received
January 25, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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