510(k) K182765

5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe by Top Corporation — Product Code FMF

K182765 is an FDA 510(k) premarket notification submitted by Top Corporation for the device "5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe". The FDA issued a decision of Substantially Equivalent on Sep 3, 2019. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 3, 2019
Date Received
Sep 28, 2018
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)