Steris Corporation (STE) Gets 510(K) Clearance on Software Modification to Liquid Sterilization System
3/6/2012 8:30:45 AM
STERIS (NYSE:STE) has received 510(k) clearance from the U.S. Food and Drug Administration for software modifications to its System 1E liquid chemical sterilization system. The modifications are related to system aborts that were caused primarily by water-temperature issues, STERIS spokesman Steve Norton said. The System 1E is a liquid chemical sterilizing system used by hospitals, surgical centers and other healthcare facilities to sterilize heat-sensitive medical instruments. It’s a replacement device for the System 1.