K211607 is an FDA 510(k) clearance for the SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate. 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 September 7, 2021, 105 days after receiving the submission on May 25, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6885.
| 510(k) Number | K211607 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 2021 |
| Decision Date | September 07, 2021 |
| Days to Decision | 105 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 |