510(k) K934370

BIP BIOPSY NEEDLE MODIFICATION by Bip USA, Inc. — Product Code FCG

K934370 is an FDA 510(k) premarket notification submitted by Bip USA, Inc. for the device "BIP BIOPSY NEEDLE MODIFICATION". The FDA issued a decision of Substantially Equivalent on March 7, 1994. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Bip USA, Inc. has at least 6 other 510(k) clearances on record.