510(k) K222852

Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle by Nipro Medical Corporation — Product Code FMI

K222852 is an FDA 510(k) premarket notification submitted by Nipro Medical Corporation for the device "Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle". The FDA issued a decision of Substantially Equivalent on May 25, 2023. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Nipro Medical Corporation has at least 10 other 510(k) clearances on record.