510(k) K232329

Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter by Medivators (A Subsidiary of Steris Corporation) — Product Code ODC

K232329 is an FDA 510(k) premarket notification submitted by Medivators (A Subsidiary of Steris Corporation) for the device "Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter". The FDA issued a decision of Substantially Equivalent on December 21, 2023. 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.