510(k) K010400

VACUUM ASSISTED CORE BIOPSY DEVICE by Promex, Inc. — Product Code KNW

K010400 is an FDA 510(k) premarket notification submitted by Promex, Inc. for the device "VACUUM ASSISTED CORE BIOPSY DEVICE". The FDA issued a decision of Substantially Equivalent on July 24, 2001. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Promex, Inc. has at least 10 other 510(k) clearances on record.