510(k) K162758 ยท JOJ Indicator, Physical/Chemical Sterilization Process
VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack
| Applicant | STERIS Corporation, Mentor OH, US |
| Decision | Substantially Equivalent, Mar 21, 2017 |
| Received | Sep 30, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162758
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 10, 2022 | Steris Corporation Hopkins Facility Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design. Terminated |
JOJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.