510(k) K905747

LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR by Coopervision Surgical — Product Code HGI

K905747 is an FDA 510(k) premarket notification submitted by Coopervision Surgical for the device "LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR". The FDA issued a decision of Substantially Equivalent on Sep 17, 1991. The device falls under product code HGI (Electrocautery, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.4120. Coopervision Surgical has 1 other 510(k) clearance on record.