510(k) K131078 ยท MED Sterilant, Medical Devices
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
| Applicant | STERIS Corporation, Mentor OH, US |
| Decision | Substantially Equivalent, Jul 5, 2013 |
| Received | Apr 17, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131078
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 4, 2015 | Steris Corporation Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapters. For sterilant a Terminated |
MED | None listed |
| Dec 31, 2013 | Steris Corporation SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH
The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical ster Terminated |
MLR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.