Enbio PRO— 510(k) K260254

Substantially Equivalent

Enbio Group AG

FDA 510(k) clearance K260254 for Enbio PRO, Substantially Equivalent on 2026-02-26. Applicant: Enbio Group AG.

Clearance details

Applicant: Enbio Group AG
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2026-01-27
Decision date: 2026-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oensingen, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.