510(k) K241426

GPS Advanced; 5 cc GPS Advanced Cannula by Prosidyan, Inc. — Product Code FMF

K241426 is an FDA 510(k) premarket notification submitted by Prosidyan, Inc. for the device "GPS Advanced; 5 cc GPS Advanced Cannula". The FDA issued a decision of Substantially Equivalent on July 10, 2024. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Prosidyan, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2024
Date Received
May 20, 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