510(k) K190054

BD Insulin Syringe by Becton, Dickinson And Company — Product Code FMF

K190054 is an FDA 510(k) premarket notification submitted by Becton, Dickinson And Company for the device "BD Insulin Syringe". The FDA issued a decision of Substantially Equivalent on Oct 21, 2019. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Becton, Dickinson And Company has 329 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 21, 2019
Date Received
Jan 11, 2019
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
510(k)