510(k) K973820

USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE by Circon Corp. — Product Code FAS

K973820 is an FDA 510(k) premarket notification submitted by Circon Corp. for the device "USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE". The FDA issued a decision of Substantially Equivalent on May 12, 1998. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Circon Corp. has at least 5 other 510(k) clearances on record.