K161683 is an FDA 510(k) clearance for the SYSTEM 1E Liquid Chemical Sterilant Processing System. This device is classified as a Sterilant, Medical Devices (Class II - Special Controls, product code MED).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on August 5, 2016, 49 days after receiving the submission on June 17, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6885.
| 510(k) Number | K161683 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2016 |
| Decision Date | August 05, 2016 |
| Days to Decision | 49 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MED — Sterilant, Medical Devices |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6885 |