510(k) K875280 ยท MED Sterilant, Medical Devices
STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT
| Applicant | Steris C/O Medical Device Consultants, Inc., North Attleboro MA, US |
| Decision | Substantially Equivalent, Sep 13, 1988 |
| Received | Dec 24, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K875280
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2008 | Steris Corp Quick Connect component p/n 201048. The component is contained in QPC1713 and QPC1724 Quick Connects. The QPC1724 is used to attach Pentax 70/70K/72/72K/80K/81K/90i/90K SERIES GI ENDOSCOPES WITH WATE Terminated |
MED | None listed |
| Jul 20, 2004 | Steris Corp QPC1680 Quick Connect, for Pentax 30/40/K Series Two-Channel GI Endoscopes, in the Steris System 1 Sterile Processing System with the C1160 Universal Flexible Processing Tray, Cat No. QPT1680 Terminated |
MED | None listed |
| Feb 6, 2003 | Steris Corp C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olympus 30/40/160/200/240 Series Bronchoscopes in the C1140 Universal Processing Trays. Catalog numbers: C11473 and QLC1473. Terminated |
MLR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.