ORiGO System— 510(k) K221184
Substantially EquivalentBien-Air Surgery SA
FDA 510(k) clearance K221184 for ORiGO System, Substantially Equivalent on 2022-11-02. Applicant: Bien-Air Surgery SA. Device class: 2.
Clearance details
- Applicant
- Bien-Air Surgery SA
- Product code
- Code ERL
- Device class
- Class 2
- Regulation
- 21 CFR 874.4250
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Le Noirmont, CH
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More clearances from Bien-Air Surgery SA
view allAdverse events under product code ERL
product code ERL- Malfunction
- 11,234
- Total
- 11,234
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.