510(k) K102462 ยท MED Sterilant, Medical Devices
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
| Applicant | STERIS Corporation, Mentor OH, US |
| Decision | Substantially Equivalent, Sep 21, 2010 |
| Received | Aug 27, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102462
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Sep 7, 2012 | Steris Corporation The SYSTEM 1E Liquid Sterilant Processing System.
The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critic Terminated |
MED | None listed |
| Jan 25, 2012 | Steris Corporation Hopkins Facility STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011.
The Terminated |
MED | None listed |
| Sep 1, 2011 | Steris Corporation SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mfr. By: STERIS Corporation, Mentor, OH 44060.
Product Usage: The SYSTEM 1E Liquid Chemical Sterilan Terminated |
MLR | None listed |
| Apr 12, 2011 | Steris Corporation Hopkins Facility STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System
The SYSTEM 1 E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned impressib Terminated |
MED | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.