510(k) K241821

Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle by Sol-Millennium Medical, Inc. — Product Code FMF

K241821 is an FDA 510(k) premarket notification submitted by Sol-Millennium Medical, Inc. for the device "Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle". The FDA issued a decision of Substantially Equivalent on September 20, 2024. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Sol-Millennium Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2024
Date Received
June 24, 2024
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