510(k) K930201

ACECUT SUTOMATIC BIOPSY SYSTEM by Meadox Surgimed, Inc. — Product Code KNW

K930201 is an FDA 510(k) premarket notification submitted by Meadox Surgimed, Inc. for the device "ACECUT SUTOMATIC BIOPSY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 9, 1993. 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.