FDA Clears Andersen Sterilizers’ Ethylene Oxide Gas Sterilizer
The FDA has granted an expanded 510(k) marketing clearance for Andersen Sterilizers’ EOGas 4, an ethylene oxide gas sterilizer, and its accessories.
The device is used to sterilize reusable medical devices that are sensitive to moisture, heat or radiation and provides six months of sterile shelf life for endoscopes following sterilization.
The agency previously cleared the device in 2015 for surface sterilization of a range of instruments and for sterilizing endoscopes less than 1,100 millimeters in length. The new clearance covers endoscopes greater than 1,100 millimeters with a maximum length of 3,530 millimeters.