510(k) K854404

ROTEX SCREW BIOPSY NEEDLE by Meadox Surgimed, Inc. — Product Code FCG

K854404 is an FDA 510(k) premarket notification submitted by Meadox Surgimed, Inc. for the device "ROTEX SCREW BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on December 2, 1985. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Meadox Surgimed, Inc. has at least 10 other 510(k) clearances on record.