510(k) K232004

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

K232004 is an FDA 510(k) premarket notification submitted by Medivators (A Subsidiary of Steris Corporation) for the device "Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector". The FDA issued a decision of Substantially Equivalent on March 6, 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.