TSO3 (TSE:TOS) said late yesterday it won expanded FDA 510(k) clearance for its Sterizone VP4 sterilizer, clearing a new feature of the system that the company claims can improve installation of the device and reduce oxygen supply requirements.
The company’s Sterizone VP4 is a low-temperature sterilization system which uses dual-sterilants of vaporized hydrogen peroxide and ozone for the terminal sterilization of heat and moisture sensitive medical devices. The system has a single pre-programmed cycle which can be used to sterilize a wide range of devices, the Quebec City-based company said.
“We are excited to incorporate this new feature to our Sterizone VP4 Sterilizer. The improvement now makes the installation of our device more cost-effective, further solidifying its position as the least expensive, on a cost per item sterilized basis, low temperature sterilizer available today relative to legacy hydrogen peroxide-based sterilizers,” TSO3 prez & CEO R.M. Rumble said in a press release.
Last November, TSO3 said it responded to a request for additional information from the FDA on its Sterizone VP4 sterilizer as it seeks an indication for the terminal sterilization of duodenoscopes.
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