510(k) K231900

A-TAP (previously called Arthrotap) by Elcam Medical Acal — Product Code FMF

K231900 is an FDA 510(k) premarket notification submitted by Elcam Medical Acal for the device "A-TAP (previously called Arthrotap)". The FDA issued a decision of Substantially Equivalent on July 25, 2023. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Elcam Medical Acal has at least 10 other 510(k) clearances on record.