510(k) K854420

MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL by Meadox Surgimed, Inc. — Product Code GDM

K854420 is an FDA 510(k) premarket notification submitted by Meadox Surgimed, Inc. for the device "MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL". The FDA issued a decision of Substantially Equivalent on November 22, 1985. The device falls under product code GDM (Needle, Aspiration And Injection, Reusable), a Class I device regulated under 21 CFR 878.4800. Meadox Surgimed, Inc. has at least 10 other 510(k) clearances on record.