510(k) K172410

Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters by Smiths Medical Asd, Inc. — Product Code BSP

K172410 is an FDA 510(k) premarket notification submitted by Smiths Medical Asd, Inc. for the device "Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters". The FDA issued a decision of Substantially Equivalent on June 1, 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.