K233026 is an FDA 510(k) clearance for the Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Midmark Corporation (Versailles, US). The FDA issued a Cleared decision on April 4, 2024, 195 days after receiving the submission on September 22, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K233026 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2023 |
| Decision Date | April 04, 2024 |
| Days to Decision | 195 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 |