510(k) K171504 ยท FRC Indicator, Biological Sterilization Process
VERIFY Assert VH2O2 Self-Contained Biological Indicator
| Applicant | STERIS Corporation, Mentor OH, US |
| Decision | Substantially Equivalent, Aug 22, 2017 |
| Received | May 23, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171504
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB053.
b. STERIS CORP VERIFY Verify SixCess Sterilization Flash Indicator Strip Steam 2-3/ Open, Classified |
FRC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.