About This 510(k) Submission
K111751 is an FDA 510(k) clearance for the VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS, a Coagulator-cutter, Endoscopic, Bipolar (and Accessories) (Class II — Special Controls, product code HIN), submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on December 2, 2011, 163 days after receiving the submission on June 22, 2011. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4150.