510(k) K061651

FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 by Apple Medical Corp. — Product Code HGI

K061651 is an FDA 510(k) premarket notification submitted by Apple Medical Corp. for the device "FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158". The FDA issued a decision of Substantially Equivalent on October 20, 2006. The device falls under product code HGI (Electrocautery, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.4120. Apple Medical Corp. has at least 8 other 510(k) clearances on record.