510(k) K163435

Entellus Medical Reinforced Anesthesia Needle by Entellus Medical, Inc. — Product Code BSP

K163435 is an FDA 510(k) premarket notification submitted by Entellus Medical, Inc. for the device "Entellus Medical Reinforced Anesthesia Needle". The FDA issued a decision of Substantially Equivalent on April 5, 2017. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Entellus Medical, Inc. has at least 10 other 510(k) clearances on record.