K232485 is an FDA 510(k) clearance for the AMSCO 600 Steam Sterilizer. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Steris (Mentor, US). The FDA issued a Cleared decision on September 13, 2023, 28 days after receiving the submission on August 16, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K232485 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2023 |
| Decision Date | September 13, 2023 |
| Days to Decision | 28 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 |