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Steris Obtains FDA 510(k) Approval For System 1E Liquid Chemical Sterilant Processing System

Steris Corporation has received FDA 510(k) clearance for the System 1E Liquid Chemical Sterilant Processing System, a 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.

Steris continues dialogue with FDA to close out the remaining System 1 issues and expects to announce a transition plan in the near future. Steris said that it is also committed to providing System 1 Customers with consumables, parts and service and accessories throughout the FDA authorised transition time period.

Steris is expected to begin accepting orders for System 1E as soon as the transition plan is announced, with delivery of the first units expected by the 2nd quarter of fiscal year 2011.

Walt Rosebrough, president and CEO at Steris, said: “We are pleased that FDA cleared System 1E for marketing. 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.”