K260254
- 510(k) number
- K260254
- Device name
- Enbio PRO
- Applicant
- Enbio Group AG CH
- Product code
- FLE — Sterilizer, Steam
- Decision date
- 2026-02-26
- Date received
- 2026-01-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K260254.pdf
Official FDA record: K260254
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.