510(k) K251648

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

K251648 is an FDA 510(k) premarket notification submitted by Prosidyan, Inc. for the device "GPS Advanced; GPS Advanced Cannula". The FDA issued a decision of Substantially Equivalent on June 24, 2025. 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.