K173493 is an FDA 510(k) clearance for the Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000. 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 February 23, 2018, 102 days after receiving the submission on November 13, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K173493 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2017 |
| Decision Date | February 23, 2018 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| 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 |