Enbio PRO— 510(k) K260254
Substantially EquivalentEnbio Group AG
FDA 510(k) clearance K260254 for Enbio PRO, Substantially Equivalent on 2026-02-26. Applicant: Enbio Group AG. Device class: 2.
Summary
Enbio Group's Enbio PRO is filed under product code FLE, steam sterilizer. The record doesn't describe it beyond the name and that code name.
Class II, 21 CFR 880.6880. General Hospital is both the classification panel and the review panel. It came in as a Traditional 510(k). The record flags it as a third-party review.
Enbio Group filed from Oensingen, Switzerland. FDA found it substantially equivalent 30 calendar days after receipt (January 27 to February 26, 2026).
Clearance details
- Applicant
- Enbio Group AG
- Product code
- Product code FLE
- Device class
- Class 2
- Regulation
- 21 CFR 880.6880
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oensingen, CH
Recent devices under product code FLE
view allMore clearances from Enbio Group AG
view allAdverse events under product code FLE
product code FLE- Malfunction
- 444
- Total
- 444
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.