SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM
FDA 510(k) clearance K101409 · decided 2010-08-02
Clearance details
- K-number
- K101409
- Device name
- SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2010-05-19
- Decision date
- 2010-08-02
- Days to decision
- 75 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
+ Add to Predicate Builder ◉ Watch STERIS Corporation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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 |
| 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 |