510(k) K191087

IntraMarX Radiopaque Markers by Anx Robotica Corp — Product Code FFX

K191087 is an FDA 510(k) premarket notification submitted by Anx Robotica Corp for the device "IntraMarX Radiopaque Markers". The FDA issued a decision of Substantially Equivalent on December 18, 2019. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Anx Robotica Corp has at least 6 other 510(k) clearances on record.