510(k) K221079

Sterile Hypodermic Syringes for Single Use by Sichuan Prius Biotechnology Co., Ltd. — Product Code FMF

K221079 is an FDA 510(k) premarket notification submitted by Sichuan Prius Biotechnology Co., Ltd. for the device "Sterile Hypodermic Syringes for Single Use". The FDA issued a decision of Substantially Equivalent on October 4, 2022. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Sichuan Prius Biotechnology Co., Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2022
Date Received
April 12, 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