STERIS Announces FDA 510(k) Clearance for SYSTEM 1E Liquid Chemical Sterilant Processing System
STERIS Corporation announces that it has received Food and Drug Administration (FDA) 510(k) clearance for the STERIS SYSTEM 1E(R) Liquid Chemical Sterilant Processing System.
The STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System is the successor to the company's SYSTEM 1 Sterile Processing System. The SYSTEM 1E is indicated for liquid chemical sterilization of cleaned, immersible and reusable critical and semi-critical heat sensitive medical devices in healthcare facilities.
"We are pleased that the Agency cleared SYSTEM 1E for marketing," commented Walt Rosebrough, STERIS president and CEO. "This is good news for our customers and we look forward to working with them as they continue their transition to acceptable alternative technologies. We remain committed to the outstanding level of service that our customers have come to expect from STERIS."
STERIS continues dialogue with the FDA to close out the remaining SYSTEM 1 issues and expects to announce a transition plan in the near future. STERIS is also committed to providing SYSTEM 1 customers with consumables, parts and service and accessories throughout the FDA authorized transition time period. The company will begin accepting orders for SYSTEM 1E as soon as the transition plan is announced, with delivery of the first units expected by the second quarter of fiscal year 2011.
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