510(k) K211211

Sterile syringes for single use with/without needle by Azur Medical Company, Inc. — Product Code FMF

K211211 is an FDA 510(k) premarket notification submitted by Azur Medical Company, Inc. for the device "Sterile syringes for single use with/without needle". The FDA issued a decision of Substantially Equivalent on October 7, 2021. 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.