510(k) K161232

ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit by Halyard Health — Product Code BSO

K161232 is an FDA 510(k) premarket notification submitted by Halyard Health for the device "ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit". The FDA issued a decision of Substantially Equivalent on September 30, 2016. The device falls under product code BSO (Catheter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5120. Halyard Health has at least 10 other 510(k) clearances on record.