510(k) K151069

SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle by Spectra Medical Devices, Inc. — Product Code BSP

K151069 is an FDA 510(k) premarket notification submitted by Spectra Medical Devices, Inc. for the device "SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle". The FDA issued a decision of Substantially Equivalent on February 5, 2016. 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, Inc. has at least 7 other 510(k) clearances on record.