About This 510(k) Submission
K964594 is an FDA 510(k) clearance for the VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG), a Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (Class II — Special Controls, product code KNF), submitted by Circon Corp. (Stamford, US). The FDA issued a Cleared decision on August 15, 1997, 273 days after receiving the submission on November 15, 1996. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.