510(k) K911635

MEADOX(R) SURGIMED(R) BIOPSY GUN II by Meadox Surgimed, Inc. — Product Code KNW

K911635 is an FDA 510(k) premarket notification submitted by Meadox Surgimed, Inc. for the device "MEADOX(R) SURGIMED(R) BIOPSY GUN II". The FDA issued a decision of Substantially Equivalent on June 20, 1991. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Meadox Surgimed, Inc. has at least 10 other 510(k) clearances on record.