510(k) K161409

M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem by Mermaid Medical A/S — Product Code KNW

K161409 is an FDA 510(k) premarket notification submitted by Mermaid Medical A/S for the device "M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem". The FDA issued a decision of Substantially Equivalent on August 2, 2016. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075.