510(k) K173155

Pakter Curved Needle Set by Cook Incorporated — Product Code BSP

K173155 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Pakter Curved Needle Set". The FDA issued a decision of Substantially Equivalent on June 7, 2018. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Cook Incorporated has at least 10 other 510(k) clearances on record.