www.fdanews.com/articles/207334-fda-clears-innovia-medicals-instrusafe-for-use-in-sterizone-vp4-sterilization
FDA Clears Innovia Medical’s InstruSafe for Use in Sterizone VP4 Sterilization
April 11, 2022
Innovia Medical’s InstruSafe instrument protection trays have received 510(k) clearance from the FDA for use in the company’s Sterizone VP4 sterilization system.
The low-temperature sterilization system can quickly process high volumes of heat and moisture-sensitive devices using vaporized hydrogen peroxide, an environmentally friendly sterilant, the St. Paul, Minn.-based company said.
The InstruSafe trays, which are used during the sterilization process and subsequent transportation and storage, are validated for use with steam and low temperature sterilization cycles.