510(k) K172823

Portex NRFit Epidural Needles by Smiths Medical Asd, Inc. — Product Code BSP

K172823 is an FDA 510(k) premarket notification submitted by Smiths Medical Asd, Inc. for the device "Portex NRFit Epidural Needles". The FDA issued a decision of Substantially Equivalent on June 12, 2018. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Smiths Medical Asd, Inc. has at least 10 other 510(k) clearances on record.