K203061 is an FDA 510(k) clearance for the Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS). This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on November 6, 2020, 29 days after receiving the submission on October 8, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K203061 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 2020 |
| Decision Date | November 06, 2020 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FLE — Sterilizer, Steam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6880 |