510(k) K231861

EndoflipTM 300 System by Covidien, LLC — Product Code FFX

K231861 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "EndoflipTM 300 System". The FDA issued a decision of Substantially Equivalent on July 21, 2023. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Covidien, LLC has at least 10 other 510(k) clearances on record.