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Steris 510(k)

This article was originally published in The Gray Sheet

Executive Summary

Sterilization firm Steris has submitted a 510(k) for a modified version of its System 1 liquid chemical sterilization system, company says Jan. 20. FDA cited Steris in a May 15, 2008, warning letter for selling a modified version of System 1 without appropriate 510(k) clearance. The original system was cleared in 1989, but Steris later modified the product, including changing the pump, connector design and software, FDA said. Steris will continue supporting the System 1 installed base by providing accessories, service and parts for at least two years

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