Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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

Related Content

Regulatory News In Brief





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts