K260254 is an FDA 510(k) clearance for the Enbio PRO. 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 26, 2026, 30 days after receiving the submission on January 27, 2026.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K260254 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 2026 |
| Decision Date | February 26, 2026 |
| Days to Decision | 30 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 |