510(k) K173029

Nipro Syringe by Nipro Medical Corporation — Product Code FMF

K173029 is an FDA 510(k) premarket notification submitted by Nipro Medical Corporation for the device "Nipro Syringe". The FDA issued a decision of Substantially Equivalent on March 30, 2018. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Nipro Medical Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2018
Date Received
September 28, 2017
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