K210279 is an FDA 510(k) clearance for the Enbio S. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Enbio Group AG (Oensingen, CH). The FDA issued a Cleared decision on October 29, 2021, 270 days after receiving the submission on February 1, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K210279 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2021 |
| Decision Date | October 29, 2021 |
| Days to Decision | 270 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 |