510(k) K170218

Vesco Medical NRFit Tip Syringes by Vesco Medical, LLC — Product Code FMF

K170218 is an FDA 510(k) premarket notification submitted by Vesco Medical, LLC for the device "Vesco Medical NRFit Tip Syringes". The FDA issued a decision of Substantially Equivalent on February 24, 2017. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Vesco Medical, LLC has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2017
Date Received
January 25, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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