About This 510(k) Submission
K192342 is an FDA 510(k) clearance for the Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories), a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II — Special Controls, product code KNS), submitted by Hangzhou AGS MedTech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on May 21, 2020, 267 days after receiving the submission on August 28, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.