510(k) K170386

BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle by Becton Dickinson & Company — Product Code FMF

K170386 is an FDA 510(k) premarket notification submitted by Becton Dickinson & Company for the device "BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle". The FDA issued a decision of Substantially Equivalent on April 12, 2017. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Becton Dickinson & Company has at least 2 other 510(k) clearances on record.