510(k) K232067

Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector by Medivators (A Subsidiary of Steris Corporation) — Product Code ODC

K232067 is an FDA 510(k) premarket notification submitted by Medivators (A Subsidiary of Steris Corporation) for the device "Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector". The FDA issued a decision of Substantially Equivalent on March 22, 2024. The device falls under product code ODC (Endoscope Channel Accessory), a Class II device regulated under 21 CFR 876.1500. Medivators (A Subsidiary of Steris Corporation) has at least 2 other 510(k) clearances on record.