510(k) K172800

Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors by Smiths Medical Asd, Inc. — Product Code MIA

K172800 is an FDA 510(k) premarket notification submitted by Smiths Medical Asd, Inc. for the device "Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors". The FDA issued a decision of Substantially Equivalent on June 14, 2018. The device falls under product code MIA (Needle, Spinal, Short Term), a Class II device regulated under 21 CFR 868.5150. Smiths Medical Asd, Inc. has at least 10 other 510(k) clearances on record.