510(k) K944450

SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE by Unimed Surgical Products, Inc. — Product Code HGI

K944450 is an FDA 510(k) premarket notification submitted by Unimed Surgical Products, Inc. for the device "SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE". The FDA issued a decision of Substantially Equivalent on July 25, 1995. The device falls under product code HGI (Electrocautery, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.4120. Unimed Surgical Products, Inc. has at least 10 other 510(k) clearances on record.