510(k) K040049 ยท NZA Accessories, Germicide, Cleaning, For Endoscopes
THE RELIANCE ENDOSCOPE PROCESSING SYSTEM
| Applicant | STERIS Corporation, Mentor OH, US |
| Decision | Substantially Equivalent, Dec 17, 2004 |
| Received | Jan 12, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040049
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2013 | Steris Corporation Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com.
The intended use of the REPS is washing and high level disinfection of up Terminated |
NZA | None listed |
| Dec 28, 2010 | Steris Corporation Steris Reliance EPS Endoscope Processing System , manufactured by Corporation STERIS Canada, Quebec, Canada.
Washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable Terminated |
MLR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.