SYSTEM 1.5 STERILE PROCESSING SYSTEM
FDA 510(k) clearance K090036 · decided 2010-04-05
Clearance details
- K-number
- K090036
- Device name
- SYSTEM 1.5 STERILE PROCESSING SYSTEM
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2009-01-06
- Decision date
- 2010-04-05
- Days to decision
- 454 days
- Clearance type
- Traditional
- Product code
- MED
- Device class
- 2
- Regulation number
- 880.6885
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, recall (Z-0616-2014) | Steris Corporation | 2013-12-31 |
| The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processin recall (Z-2335-2012) | Steris Corporation | 2012-09-07 |
| QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray f recall (Z-2284-2012) | Steris Corporation | 2012-08-28 |
| STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers recall (Z-0869-2012) | Steris Corporation Hopkins Facility | 2012-01-25 |
| SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through recall (Z-3124-2011) | Steris Corporation | 2011-09-01 |
| STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System The SYSTEM 1 E Liquid Chemica recall (Z-1960-2011) | Steris Corporation Hopkins Facility | 2011-04-12 |