510(k) K213697— ORiGO System

Substantially Equivalent

Bien-Air Surgery SA

Clearance details

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

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.