K214057 is an FDA 510(k) clearance for the STATIM 6000B Vacuum Autoclave. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Scican , Ltd. (Toronto, CA). The FDA issued a Cleared decision on March 31, 2022, 94 days after receiving the submission on December 27, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K214057 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2021 |
| Decision Date | March 31, 2022 |
| Days to Decision | 94 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FLE - Sterilizer, Steam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6880 |