ORiGO System— 510(k) K213697

Name: FDA 510(k) clearance K213697
Creator: U.S. Food and Drug Administration
Published: 2022-10-31

Substantially Equivalent

Bien-Air Surgery SA

FDA 510(k) clearance K213697 for ORiGO System, Substantially Equivalent on 2022-10-31. Applicant: Bien-Air Surgery SA. Device class: 2.

Clearance details

Applicant: Bien-Air Surgery SA
Product code: Code HBC
Device class: Class 2
Regulation: 21 CFR 882.4360
Advisory panel: Neurology
Date received: 2021-11-23
Decision date: 2022-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Le Noirmont, CH

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HBC

product code HBC

Malfunction: 4,715
Total: 4,715

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.