510(k) K211210

Sterile Auto-Disable Syringes with/without Needle for Single Use by Azur Medical Company, Inc. — Product Code FMF

K211210 is an FDA 510(k) premarket notification submitted by Azur Medical Company, Inc. for the device "Sterile Auto-Disable Syringes with/without Needle for Single Use". The FDA issued a decision of Substantially Equivalent on January 27, 2022. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Azur Medical Company, Inc. has at least 3 other 510(k) clearances on record.