510(k) K211909

Cysto-Gastro-Sets by G-Flex Europe Sprl — Product Code KNS

K211909 is an FDA 510(k) premarket notification submitted by G-Flex Europe Sprl for the device "Cysto-Gastro-Sets". The FDA issued a decision of Substantially Equivalent on June 9, 2022. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. G-Flex Europe Sprl has at least 1 other 510(k) clearance on record.