K173256 is an FDA 510(k) clearance for the System 1 endo 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 March 2, 2018, 143 days after receiving the submission on October 10, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6885.
| 510(k) Number | K173256 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 2017 |
| Decision Date | March 02, 2018 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| 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 |