510(k) K142791

Spectra Soft Tissue Biopsy Needles by Spectra Medical Devices — Product Code KNW

K142791 is an FDA 510(k) premarket notification submitted by Spectra Medical Devices for the device "Spectra Soft Tissue Biopsy Needles". The FDA issued a decision of Substantially Equivalent on January 21, 2015. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Spectra Medical Devices has at least 7 other 510(k) clearances on record.