510(k) K081323

BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 by B-K Medical Aps — Product Code FCG

K081323 is an FDA 510(k) premarket notification submitted by B-K Medical Aps for the device "BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818". The FDA issued a decision of Substantially Equivalent on Jul 22, 2008. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. B-K Medical Aps has 10 other 510(k) clearances on record.