About This 510(k) Submission
K973820 is an FDA 510(k) clearance for the USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE, a Electrode, Electrosurgical, Active, Urological (Class II — Special Controls, product code FAS), submitted by Circon Corp. (Santa Barbara, US). The FDA issued a Cleared decision on May 12, 1998, 217 days after receiving the submission on October 7, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.