510(k) K203792

Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle by Pikdare Spa — Product Code FMI

K203792 is an FDA 510(k) premarket notification submitted by Pikdare Spa for the device "Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle". The FDA issued a decision of Substantially Equivalent on Jan 20, 2023. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Pikdare Spa has 1 other 510(k) clearance on record.