K190104 is an FDA 510(k) clearance for the SYSTEM 1E Liquid Chemical Sterilant Processing System, 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 Corporations (Mentor, US). The FDA issued a Cleared decision on March 22, 2019, 59 days after receiving the submission on January 22, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6885.
| 510(k) Number | K190104 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2019 |
| Decision Date | March 22, 2019 |
| Days to Decision | 59 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 |