K213991 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 February 22, 2022, 63 days after receiving the submission on December 21, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K213991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2021 |
| Decision Date | February 22, 2022 |
| Days to Decision | 63 days |
| Submission Type | Special |
| 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 |