SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
FDA 510(k) clearance K113520 · decided 2012-02-21
Clearance details
- K-number
- K113520
- Device name
- SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2011-11-29
- Decision date
- 2012-02-21
- Days to decision
- 84 days
- Clearance type
- Special
- 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 |
| Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44 recall (Z-1596-2013) | Steris Corporation | 2013-06-26 |