Enbio S— 510(k) K210279

Name: FDA 510(k) clearance K210279
Creator: U.S. Food and Drug Administration
Published: 2021-10-29

Substantially Equivalent

Enbio Group AG

FDA 510(k) clearance K210279 for Enbio S, Substantially Equivalent on 2021-10-29. Applicant: Enbio Group AG. Device class: 2.

Clearance details

Applicant: Enbio Group AG
Product code: Code FLE
Device class: Class 2
Regulation: 21 CFR 880.6880
Advisory panel: General Hospital
Date received: 2021-02-01
Decision date: 2021-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oensingen, CH

Download summary PDF View on FDA.gov ↗

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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.