510(k) K242434

Insulin Syringes by Chirana T. Injecta — Product Code FMF

K242434 is an FDA 510(k) premarket notification submitted by Chirana T. Injecta for the device "Insulin Syringes". The FDA issued a decision of Substantially Equivalent on December 24, 2024. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Chirana T. Injecta has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 2024
Date Received
August 16, 2024
Clearance Type
Special
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