Submission Details
| 510(k) Number | K230582 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 02, 2023 |
| Decision Date | March 28, 2023 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
K230582 is an FDA 510(k) clearance for the SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, 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 28, 2023, 26 days after receiving the submission on March 2, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6885.
| 510(k) Number | K230582 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 02, 2023 |
| Decision Date | March 28, 2023 |
| Days to Decision | 26 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 |