K091731 is an FDA 510(k) clearance for the AMSCO EVOLUTION MEDIUM STEAM STERILIZER. 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 September 17, 2009, 98 days after receiving the submission on June 11, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K091731 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2009 |
| Decision Date | September 17, 2009 |
| Days to Decision | 98 days |
| Submission Type | Abbreviated |
| 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 |