510(k) K231558

SMB Luer lock disposable syringe by Smb Corporation of India — Product Code FMF

K231558 is an FDA 510(k) premarket notification submitted by Smb Corporation of India for the device "SMB Luer lock disposable syringe". The FDA issued a decision of Substantially Equivalent on January 12, 2024. 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
January 12, 2024
Date Received
May 30, 2023
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