K213545 is an FDA 510(k) clearance for the Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Steelco S.P.A. (Riese Pio X, IT). The FDA issued a Cleared decision on February 2, 2023, 451 days after receiving the submission on November 8, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K213545 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2021 |
| Decision Date | February 02, 2023 |
| Days to Decision | 451 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 |