510(k) K163292

Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford by Spectra Medical Devices — Product Code BSP

K163292 is an FDA 510(k) premarket notification submitted by Spectra Medical Devices for the device "Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford". The FDA issued a decision of Substantially Equivalent on September 8, 2017. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Spectra Medical Devices has at least 7 other 510(k) clearances on record.