510(k) K250262

GO-PEN® by Go-Pen Aps — Product Code FMF

K250262 is an FDA 510(k) premarket notification submitted by Go-Pen Aps for the device "GO-PEN®". The FDA issued a decision of Substantially Equivalent on Apr 24, 2025. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860.