510(k) K192342

Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) by Hangzhou AGS MedTech Co., Ltd. — Product Code KNS

K192342 is an FDA 510(k) premarket notification submitted by Hangzhou AGS MedTech Co., Ltd. for the device "Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)". The FDA issued a decision of Substantially Equivalent on May 21, 2020. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Hangzhou AGS MedTech Co., Ltd. has at least 10 other 510(k) clearances on record.